Protocol summary
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Study aim
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Determining the effect of using platelet rich fibrin(PRF) together with Aloderm versus Aloderm alone and free gingival grafts(fgg) on increasing the amount of keratinized risks around the implant.
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Design
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The current study is designed as a randomized, controlled, double-blind trial
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Settings and conduct
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Kerman university of medical science; faculty of dentistry
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Participants/Inclusion and exclusion criteria
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1. Older than 18 years. 2. Less than 2 mm Keratinized Tissue at the buccal location of the crest ridge on the implant. 3. The presence of healthy tissue around the implant 4. Plaque index and bleeding index below 20% 5. Good general health. 1. Smokers and alcoholics (more than 10 cigarettes). 2. Patients with systemic diseases that can interfere with recovery. 3. Patients treated with bisphosphonate and patients who have already received jaw radiotherapy. 4. Patients with moderate to severe periodontitis. 5. Pregnant women and nursing mothers.
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Intervention groups
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group 1: In this group, soft tissue augmentation around the implant is performed by Aloderm alone group 2: In this group, soft tissue augmentation around the implant is performed by Alloderm along with prf group 3: In this group, soft tissue augmentation around the implant is performed by fgg
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Main outcome variables
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the width of keratinized tissue around dental implants
General information
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Reason for update
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The abbreviation PRF in the title was mistakenly written as Platelet Rich Plasma, which is actually Fibrin Rich Plasma.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20101204005305N22
Registration date:
2024-11-10, 1403/08/20
Registration timing:
prospective
Last update:
2025-08-11, 1404/05/20
Update count:
1
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Registration date
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2024-11-10, 1403/08/20
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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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2024-12-30, 1403/10/10
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Expected recruitment end date
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2025-01-30, 1403/11/11
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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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The comparison of Alloderm with platelet rich fibrin(PRF) Vs free gingival grafts Vs Alloderm to increase the width of keratinized tissue around dental implants : a randomised controlled trial
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Public title
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The comparison of platelet-rich-fibrin impregnated alloderm Vs free gingival grafts Vs Alloderm to increase keratinized gingival width around dental implants
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
less than 2mm keratinized gingiva
healthy periimplant tissue
plaque index and bleeding index less than 20%
good overal health
Exclusion criteria:
smokers(more than 10 cigarettes per day)
Patients with systemic diseases that can interfere with recovery.
Patients treated with bisphosphonates and patients who have previously received jaw radiotherapy.
Patients with moderate to severe periodontitis.
Pregnant women and nursing mothers.
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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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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
36
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization of patients is done by block randomized method, which is as follows: 3 sequences of 12 letters A’B’C are produced and people are entered into the study in groups of 12, then each sequence is removed from its envelope and people Based on it, they are assigned to study groups
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The need to increase the width of the attached gingiva in these people was determined by a periodontist who does not know the type of treatment. A clinician that is blind to the study will perform all measurements. Patients in all groups receive surgery, but they are not informed about the surgical technique that is performed. However, care and complications after surgery are comprehensively explained
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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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2024-09-08, 1403/06/18
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Ethics committee reference number
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IR.KMU.REC.1403.238
Health conditions studied
1
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Description of health condition studied
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width of keratinized tissue around dental implants
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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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width of keratinized tissue around dental implants
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Timepoint
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Keratinized gingival width is achieved in patients 3 months after surgery
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Method of measurement
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A periodontal probe is used to measure the distance between the gingival margin and the mucogingival junction.
Secondary outcomes
1
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Description
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The depth of the vestibule
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Timepoint
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3 months after surgery
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Method of measurement
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The distance from the gingival margin to the deepest part of the vestibule
Intervention groups
1
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Description
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Intervention group: 1- First, ten milliliters of whole venous blood will be collected in two sterile PRF preparation tubes of ten milliliters.2- The tubes will be inserted into the centrifuge at a speed of 700 rpm for 3 minutes.3- Blood is divided into three layers. A cell-free plasma, a middle section containing a fibrin clot, and a red section containing red blood cells at the bottom of the tube.4- PRF is drawn with a syringe.5- Then Eloderm is prepared in the same way as described in the previous group6- Now Alloderm with PRF will be mixed and fixed with periosteal sutures using 0-5 non-absorbable nylon suture material on the recipient site.
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Category
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Treatment - Surgery
2
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Description
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Intervention group:In the ADM group, the acellular dermal matrix (AlloDerm®) will be prepared and applied according to the manufacturer's instructions. In summary:1- The membrane will be hydrated with 50 ml of sterile saline solution for 5 minutes.2- When the protective backing paper is removed, the ADM substance will be transferred to another container containing 50 ml of sterile serum solution and will be left there for 5 minutes.3- Then, the allograft will be cut to a size of one by two centimeters4- It will be fixed on the recipient site with periosteal sutures using 0-5 non-absorbable nylon suture material.
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Category
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Treatment - Surgery
3
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Description
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Control group:For the control group:1. Taking a 1 to 2 mm thick FGG from the palate, depending on the amount of tissue in the palate of each patient and with dimensions of 1 x 1.5 cm2. Placement and fixation of FGG on the recipient surface with crossed sutures and non-absorbable sutures (Nylon 5.0, Ethilon®).
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Category
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Treatment - Surgery
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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Yes
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Title of funding source
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Kerman 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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Undecided - It is not yet known if there will be a plan to make this available
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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