Condition category
Oral Health
Date applied
17/08/2020
Date assigned
20/08/2020
Last edited
20/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jihad Yasin ALsahli

ORCID ID

http://orcid.org/0000-0003-4672-3565

Contact details

Damascus University
Faculty of Dental Medicine
Almazah Highway
Damascus
-
Syria
+963 (0)956854471
dr.jihad1992@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

3296\m

Study information

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

Acronym

Study hypothesis

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

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

Study design

Randomized clinical split-mouth study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

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 trial start date

06/12/2018

Overall trial end date

12/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15

Total final enrolment

14

Participant 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

Recruitment start date

01/01/2019

Recruitment end date

05/06/2019

Locations

Countries of recruitment

Syria

Trial participating centre

Damascus University
Faculty of Dental Medicine Almazah Highway
Damascus
-
Syria

Sponsor information

Organisation

Damascus University

Sponsor details

Damascus
Damascus
-
Syria
+963 (0)113341864
manager@hcsr.gov.sy

Sponsor type

University/education

Website

http://damasuniv.edu.sy/

Funders

Funder type

University/education

Funder name

Damascus University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Intention to publish date

16/10/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

20/08/2020: Trial’s existence confirmed by Ethical Committee of the Faculty of Dental Medicine (Damascus University)