Protocol summary
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Study aim
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Radiographic and clinical comparison of 4 methods of filling the buccal gap of immediate implants using extended platelet-rich fibrin(e_PRF), leukocyte- and platelet-rich fibrin(l_PRF), xenograft, no gap filling
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Design
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A randomized clinical trial with a control group and sample concealment, blinding with parallel groups, is being conducted on 48 patients in 4 groups.
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Settings and conduct
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Patients for immediate implant placement, if they meet the entry criteria, are randomly assigned to each group, consisting of 12 people. Based on the block randomization method, they are divided into 4 groups:
Immediate implant and no buccal gap filling
Immediate implant and buccal gap filling using xenograft
Immediate implant and buccal gap filling using L-PRF
Immediate implant and buccal gap filling using e-PRF
Blinding is performed during the radiographic data collection stage and the individuals who collect the soft tissue topography scan files and during the statistical data analysis stage.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria
Systemic health and no drug or alcohol addiction
Type 1 socket
Plaque index less than 20%
buccal gap greater than mm2
Exclusion criteria
infection, deep probing depth, and initial implant instability
Need for simultaneous bone grafting
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Intervention groups
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The control group does not place any material in the buccal gap.
The Xenograft group, Serabone, is packed in the buccal gap.
The third group, L-PRF, is placed at a setting of 2700 for 12 minutes.The fourth group, e-PRF, is placed in the buccal gap.after blood collection, centrifugation is performed at 700 for 8 minutes, a layer of Poor Plasma Fibrin is placed in the heater to coagulate proteins and mixed with PRF.
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Main outcome variables
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Percentage of implant height covered by bone in buccal, measurement of the distance between the external surface of the bone and the implant shoulder
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20251004067496N1
Registration date:
2026-01-08, 1404/10/18
Registration timing:
registered_while_recruiting
Last update:
2026-07-04, 1405/04/13
Update count:
1
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Registration date
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2026-01-08, 1404/10/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-11-22, 1404/09/01
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Expected recruitment end date
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2026-03-21, 1405/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Radiographic and clinical comparison in 4 methods of filling the buccal gap of immediate dental implants using l-PRF،ePRF،Xenograft and without gap filling a randomized clinical trial
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Public title
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Radiographic and clinical comparison of buccal gap filling methods in immediate implants.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Systemically healthy patient
Patients who are at least 18 years old
The tooth socket must be type 1 (buccal soft tissue and buccal and lingual bone plates must be intact)
Non-molar teeth that cannot be maintained
Immediate implant placement (achieving initial stability of at least 35Ncm) is possible without moving the flap and there is sufficient intraocclusal space.
It is possible to place an implant fixture with a horizontal buccal gap greater than 2 mm.
A person with adequate oral hygiene with a plaque index less than or equal to 20 percent
Exclusion criteria:
People who smoke or are addicted to drugs or alcohol
People who are pregnant or have systemic diseases such as diabetes, or if they are taking antibiotics or drugs that weaken the immune system such as corticosteroids.
Probing depth greater than three millimeters buccally or lingually
The need for bone grafting at the same time as implant placement
Presence of local or systemic conditions that are contraindications to implant placement
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization is performed using software and a sealed envelope tool is used. Blinding is performed during the clinical data collection phase (soft tissue thickness measurement is performed by a dentist who is unaware of the grouping before surgery) and review of scan files and statistical analysis.
The person taking the radiographic measurements is also unaware of the study grouping (only after 3 months of surgery is the xenograft group distinguished from the other groups due to the observation of bone particles on the radiograph).
The participants in the study are not blinded.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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during the clinical data collection phase (soft tissue thickness measurement is performed by a dentist who is unaware of the grouping before surgery) and review of scan files and statistical analysis.
The person taking the radiographic measurements is also unaware of the study grouping (only after 3 months of surgery is the xenograft group distinguished from the other groups due to the observation of bone particles on the radiograph).
The participants in the study are not blinded.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2025-11-10, 1404/08/19
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Ethics committee reference number
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IR.KMU.REC.1404.439
Health conditions studied
1
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Description of health condition studied
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People with systemic health conditions
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Buccal bone thickness (post-surgery): Linear measurement of the distance between the external surface of the bone and the implant shoulder at distances of 0, 2, 4, and 6 mm from the implant shoulder perpendicular to the long axis of the implant.
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Timepoint
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At the beginning of the study and 3 months after surgery
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Method of measurement
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Measurements of the width of the socket in the coronal and apical sections, perpendicular to the longitudinal axis of the socket, are made linearly on the 3D image DIACOM file, by a person who is unaware of the grouping.
2
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Description
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Implant coverage by bone: Percentage of implant height covered by bone in the buccal areas.
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Timepoint
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3 months after surgery
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Method of measurement
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Bone thickness and height (percentage of implant covered by bone both buccally and lingually) are performed linearly on the 3D image dycom file by a person who is unaware of the grouping.
Secondary outcomes
1
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Description
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Soft tissue thickness
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Timepoint
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Beginning of the intervention and three months later
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Method of measurement
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Endo file and gauge
2
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Description
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Distance of the gingival margin from the edge of the healing abutment
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Timepoint
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Beginning of the intervention and three months later
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Method of measurement
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Periodontal probe, parallel to the longitudinal axis of healing
3
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Description
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Keratinized gingival width
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Timepoint
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Beginning of the intervention and three months later
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Method of measurement
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Periodontal probe
4
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Description
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Soft tissue contour
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Timepoint
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Before the intervention and three months later
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Method of measurement
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Preparation of a digital file of the buccal soft tissue contour in format standard tessellation language and superimposition format to examine changes in the soft tissue contour.
Intervention groups
1
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Description
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Intervention group: In the Xenograft group, cera bone with particle sizes of 150-1000 microns was hydrated in normal saline for 10 minutes and packed in the buccal gap area up to the bone crest area.
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Category
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Other
2
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Description
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Intervention group: In the L-PRF group, after blood collection from the brachial artery, it is placed in 2 red 9 ml test tubes in a centrifuge at 2700 rpm for 12 minutes. After this time, the obtained L-PRF is separated from the red blood cells and packed by the special area in the PRF kit to produce L-PRF plug.
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Category
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Other
3
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Description
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Intervention grouIn the buccal gap filling e-PRF group, after blood collection from the brachial artery in a 9 ml white test tube, it is centrifuged at 700 rpm for 8 minutes. After that, to prepare e-PRF, first 2 ml of the liquid was obtained. In the test tube, which is PPP (platelet poor plasma), it is aspirated using a 3 ml locking syringe And this syringe is placed in a heater for 10 minutes at 75°C to coagulate the proteins. During this time, the test tubes are placed in the refrigerator to prevent coagulation. After ten minutes, the syringes are removed from the heater and placed in the refrigerator to reach room temperature, and the centrifuge tubes are removed from the refrigerator and their plastic lids are opened and the L-PRF layer and buffy coat are aspirated using a locking syringe. The syringe containing the PPP is coagulated and PRF is connected using the syringe connector, and the contents of the syringe are mixed and injected into the buccal gap and packed up to the gingival margin using a condenser.
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Category
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Other
4
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Description
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Control group: In the control group, no material is placed in the buccal gap.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available