The use of a blood protein (A-PRF) to enhance the replacement and recovery of gum tissue around tooth implants
| ISRCTN | ISRCTN33695429 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33695429 |
| Secondary identifying numbers | 3296\m |
- Submission date
- 17/08/2020
- Registration date
- 20/08/2020
- Last edited
- 30/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Mucogingival surgery is a form of plastic surgery used to correct the effects of recession caused by gum disease (periodontitis) or poor developmental anatomy or traumatic toothbrushing. It is usually indicated to improve the gum thickness to reduce the risk of further recession, reduce dental sensitivity, in some cases cover the roots. In severe cases, it can improve the life span of the teeth treated. The ability to achieve root coverage reduces with increasing extent of recession. Mucogingival surgery usually involves transfer of a small amount of gum from the palate to the area in question. This will provide an area of tough and thick gum that will be easier to maintain clean and in turn reduce the risk of the recession worsening. Whereas, the donor site in the palate will heal very readily with new tissue.
Advanced Platelet Rich Fibrin (APRF) is a new advanced technology that helps heal wounds anywhere in the body, including those involved in oral surgery, using the patient’s own blood.
The aim of this study was to evaluate the efficacy of Advanced platelet-rich fibrin (A-PRF) with Apically Positioned flap (APF) compared to Free Gingival Grafts (FGG) with APF.
Who can participate?
Adults over 20 years of age requiring a replacement for missing teeth
What does the study involve?
As this is a split-mouth study, each participant will receive two different treatments, one on each side of the mouth (order chosen randomly). Participants are followed up for 6 months.
What are the possible benefits and risks of participating?
Benefit: recovery of function to the affected area
Risks: The procedure and recovery can be painful
Where is the study run from?
Faculty of Dental Medicine, Damascus University (Syria)
When is the study starting and how long is it expected to run for?
December 2018 to December 2019
Who is funding the study?
Investigator self-funded and partially funded by Damascus University
Who is the main contact?
Jihad ALsahli, dr.jihad1992@gmail.com
Contact information
Scientific
Damascus University
Faculty of Dental Medicine
Almazah Highway
Damascus
-
Syria
 ORCID ID |
0000-0003-4672-3565 |
|---|---|
| Phone | +963 (0)956854471 |
| dr.jihad1992@gmail.com |
Study information
| Study design | Randomized clinical split-mouth study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Evaluation of apically positioned flap with A-PRF vs free gingival grafts to enhance the width of keratinized tissue around dental implants: a randomized clinical split-mouth study |
| Study objectives | There is a significant difference between using apically positioned flap with A_PRF Vs. free gingival grafts to enhance the width of keratinized tissue around dental implants |
| Ethics approval(s) | Approved 06/08/2018, Ethical Committee of the Faculty of Dental Medicine (Damascus University, Damascus, Syria; +963 (0)113341864; manager@hcsr.gov.sy), ref: 3296\m |
| Health condition(s) or problem(s) studied | Partially edentulous and requiring a replacement for missing teeth |
| Intervention | Test group (Apical position flap + Advanced platelet rich fibrin) Control group (Free gingival graft) Both test and control groups were treated in the same surgical session and patients were scheduled for postoperative follow up after 1 week, 4 weeks, 8 weeks, and 6 months after the surgery for both groups. Patients were randomly assigned to a test group (A-PRF) or a control group (FGG) in a split mouth design, via a randomization table; by a computer-generated randomization list (SPSS v23.0). The treatment methods (15 for A-PRF test group / 15 for FGGs control group). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1.Width of keratinized tissue was measured using a vacuum stent with periodontal probe from the lingual edge side of the stent to the mucogingival junction at baseline, immediately after the surgery, and 8 weeks later 2. Gingival thickness (phenotype) was measured using an acrylic stent, with an average of three measurements, at baseline, 8 weeks, and 6 months after the surgery |
| Secondary outcome measures | Postoperative pain was measured using a visual analog scale (VAS) from 0 (absence of pain) to 100 (most severe pain) on the day of surgery, and afterwards daily until day 6 |
| Overall study start date | 06/12/2018 |
| Completion date | 12/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 15 |
| Total final enrolment | 14 |
| Key inclusion criteria | 1. Older than 18 years old 2. Less than 2 mm of KT at the buccal site from the ridge crest on bilateral implants 3. Patients have a thick gingival phenotype (GT ≥ 2 mm) 4. Adequate oral hygiene (API≤1) (API= Approximal Plaque Index) and good general health |
| Key exclusion criteria | 1. Smokers and alcoholics (≥10 cigarettes/day) 2. Patients with systemic diseases that could interfere with the healing 3. Patients undergoing bisphosphonate treatment and patients who previously received radiotherapy for the jaws 4. Patients with moderate to severe periodontitis 5. Pregnant women and breastfeeding mothers |
| Date of first enrolment | 01/01/2019 |
| Date of final enrolment | 05/06/2019 |
Locations
Countries of recruitment
- Syria
Study participating centre
Almazah Highway
Damascus
-
Syria
Sponsor information
University/education
Damascus
Damascus
-
Syria
| Phone | +963 (0)113341864 |
|---|---|
| manager@hcsr.gov.sy | |
| Website | http://damasuniv.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 16/10/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 03/03/2021 | 30/04/2021 | Yes | No |
Editorial Notes
30/04/2021: Publication reference added.
20/08/2020: Trial’s existence confirmed by Ethical Committee of the Faculty of Dental Medicine (Damascus University)
