Comparison of the effect of injection of platelet-rich fibrin gel (Alb-PRF) and hyaluronic acid filler on interdental papilla reconstruction, a randomized clinical trial
Comparison of the effect of injection of platelet-rich fibrin gel and hyaluronic acid filler on interdental papilla reconstruction
Design
This study is a clinical trial with two intervention groups: injection of hyaluronic acid filler and platelet-rich fibrin gel in the interdental papilla.
This double-blind study will be performed on 66 patients (33 patients in each group with a 20% reduction in probability and 26 patients in each group). For randomization, the block randomization method with the size of 4 and 6 blocks in both intervention and control groups is used.
Settings and conduct
In this study, hyaluronic acid or Alb-PRF gel prepared from the peripheral blood of patients was randomly injected into the analyzed interdental papillae of Nordland Class I and II. Alb-PRF is prepared according to the protocol by preparing 9 ml of whole blood without adding any additives. Papillary changes will be assessed by photograph and Williams periodontal probe at 0, 3 and 6 months.
At the end of month 6, patients 'satisfaction with the beauty of appearance will be assessed using the Visual Analogue Scale (VAS) from 0 to 100 according to the patients' initial clinical pictures.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Conscious written consent to participate in the study
at least one incomplete papilla
Class I or II papillary defects according to the Nordland and Tarnow classifications
Probing depth ≤4 mm
Criteria for non-inclusion in the study:
Gingivitis or periodontium
History of periodontal surgery in the last 6 months in the area
Open interdental contact (diastem) in the area
Taking medications that cause gingival hyperplasia
Intervention groups
1. Hyaluronic acid group
2. Platelet-rich fibrin gel group
Main outcome variables
Filling of interdental papilla; interdental hygiene promotion; esthetics
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130813014350N4
Registration date:2022-04-06, 1401/01/17
Registration timing:registered_while_recruiting
Last update:2022-04-06, 1401/01/17
Update count:0
Registration date
2022-04-06, 1401/01/17
Registrant information
Name
Bardia Vadiati Saberi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1326 3622
Email address
bardia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of injection of platelet-rich fibrin gel (Alb-PRF) and hyaluronic acid filler on interdental papilla reconstruction, a randomized clinical trial
Public title
Comparison of the effect of injection of platelet-rich fibrin gel and hyaluronic acid filler on interdental papilla reconstruction, a randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written informed consent to participate in the study
Having at least one deficient papilla
Class I or II papillary defects according to the Nordland and Tarnow classifications
Probing depth ≤4 mm
Age between 20-75
Exclusion criteria:
Gingivitis or periodontitis
Diabetes, connective tissue diseases and other systemic diseases affecting periodontal tissues
History of allergic reaction
Pregnant and lactating women
History of periodontal surgery in the area in the last 6 months
Open contact (diastem) in the area
Medications that cause gingival hyperplasia
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method with 4 and 6 block sizes will be performed in both intervention and control groups. It should be noted that if the patient has more than one eligible incomplete papilla, these papillae are assigned to the same treatment group. Random allocation sequence generation is done using the site www.sealedenvelope.com.
Allocation concealment is performed using opaque numbered, stamped and sealed randomly sequenced (SNOSE) envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
This test will be double-blinded. In this study, due to blood sampling in one group, it is not possible to blind the patient, and in any case, the patient will know in which group he will be studied. Also, due to the apparent difference between the two substances and the Alb-PRF preparation, it is not possible to blind the sample allocator. Therefore, in the present study, the outcome evaluator is not aware of the injectable substance in each papilla. Also, the analyst of the study results will not know about the study groups. A code will be assigned to each of the treated papillae for statistical analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of guilan University of Medical Sciences
Street address
Bustan Mellat, Ahmadzadeh Blvd., Shahid Amini Alley, Parvaneh dead end, No. 103, Rose Building
City
Rasht
Province
Guilan
Postal code
4174734681
Approval date
2022-03-10, 1400/12/19
Ethics committee reference number
IR.GUMS.REC.1400.604
Health conditions studied
1
Description of health condition studied
reconstruction of incomplete interdental papilla
ICD-10 code
K06.0
ICD-10 code description
Gingival recession
Primary outcomes
1
Description
interdental papilla fill (black triangle area change)
Timepoint
0, 3, 6 months
Method of measurement
Measure the area of black triangles at specified intervals and examine the area changes in Photoshop
Secondary outcomes
1
Description
Patients' satisfaction with the results of the intervention
Timepoint
at the end of the sixth month
Method of measurement
visual analogue scale
2
Description
Plaque index on the treated teeth
Timepoint
At the beginning and end of the study (0 and 6 months)
Method of measurement
Loe index, the amount of microbial plaque accumulated on the treated teeth (especially in the interproximal area)
Intervention groups
1
Description
The treatment protocol was divided into 3 stages: pre-injection stage, or examination, injection stage and follow-up stage.The first visit will begin with the collection of demographic information, medical history and dentistry. Conscious consent is signed by patients. Primary periodontal treatment includes scaling and debridement of the gums. Plaque index is recorded in the teeth of the treated area. The distance between the tooth contact and the bone crest is measured by parallel periapical radiography. Before starting the test, the interdental papilla is evaluated according to the Nordland and Tarnow classifications and will be recorded in the relevant tables. Clinical photographs perpendicular to the target teeth will also be taken. Black triangles are measured clinically from the tip of the papilla to the point of interdental contact using a Williams periodontal probe and an acrylic stent...Intervention group: Hyaluronic acid filler injection............ After injection of local anesthesia, a hyaluronic acid filler with an approximate amount of less than 0.2 ml, 2-3 mm apical from the papilla tip and at an angle of 45 degrees to the longitudinal axis of the tooth will be injected with a 30 gauge insulin syringe. Patients will then be instructed in oral and written care after the injection. Patients are recalled in for a booster dose three weeks later.
Category
Treatment - Other
2
Description
Intervention group: Platelet-rich fibrin gel injection.......Preparation of Alb-PRF:From each patient, 9 ml of whole blood is collected in a plastic tube and immediately centrifuged at 700 g at room temperature for 8 minutes. After centrifugation, the top 2 ml layer (PPP) is collected in 2 ml syringes and heated at 75 ° C for 10 minutes to prepare a denatured albumin gel. The tube is then allowed to reach room temperature again for 10 minutes. Liquid PRF (layer on RBC) containing residual cells and growth factors is mixed with albumin gel and Alb-PRF gel is prepared ready for injection.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Guilan School of Dentistry
Full name of responsible person
Dr. Bardia Vadiati Saberi
Street address
Saravan-Fouman road
City
Rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 3348 6406
Email
dental@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyede Sana Alavi
Street address
Saravan-Fouman road
City
Rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 3348 6406
Email
dental@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dental Research Centre, Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Bardia Vadiati Saberi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Saravan-Fouman road
City
Rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 1326 3622
Email
bardia@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Bardia Vadiati Saberi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Saravan-Fouman road
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 1326 3622
Email
bardia@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Bardia Vadiati Saberi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
saravan-fouman road
City
Rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 1326 3622
Email
bardia@gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Comparison of the effect of injection of platelet-rich fibrin gel and hyaluronic acid filler on interdental papilla reconstruction, a randomized clinical trial
When the data will become available and for how long
6-12 months after result publication
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Use in higher level studies such as systematic review studies
From where data/document is obtainable
ا Bardia@gums.ac.ir
What processes are involved for a request to access data/document
Documents for writing a review article (for example, an invitation letter from the journal) should be provided