Testing a new treatment for receding gums

ISRCTN	ISRCTN46963726
DOI	https://doi.org/10.1186/ISRCTN46963726
Secondary identifying numbers	2400/S.M

Submission date: 01/05/2021
Registration date: 13/05/2021
Last edited: 09/07/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Background and study aims
Gingival recession (also known as receding gums) is when the gum tissue surrounding the teeth wears away or pulls back, exposing more of the tooth or its root. The aim of the study is to assess the effectiveness of an injectable blood extract with a gum graft during receding gums treatment.

Who can participate?
Healthy adults aged 19 and over who are non-smokers

What does the study involve?
Participants are randomly allocated to one of two treatment methods, one will involve applying the gum graft alone on the diseased tooth, while the other will involves applying an injectable blood extract before applying a gum graft on it. Participants are followed up to measure gum recession at 1, 3 and 6 months.

What are the possible benefits and risks of participating?
The possible benefits of participating are achieving full coverage for receding gums sites, less pain and better healing. The methods are safe and there are no expected risks.

Where is the study run from?
Damascus University (Syria)

When is the study starting and how long is it expected to run for?
May 2020 to July 2022

Who is funding the study?
Damascus University (Syria)

Who is the main contact?
Dr Wajiha Albattal
wajihaalbatal@gmail.com

Contact information

Dr Wajiha Albatal
Scientific

Dummar
Damascus
00000
Syria

ORCID ID	0000-0002-0250-8380
Phone	+963 (0)930429851
Email	wajihaalbatal@gmail.com

Study information

Study design	Single-center interventional double-blinded randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a participant information sheet
Scientific title	The efficiency of injectable platelet-rich fibrin (i-PRF) in root surface biomodification during gingival recession treatment
Study hypothesis	Injectable platelet-rich fibrin (i-PRF) with free gingival graft provides better root coverage compared to a free gingival graft alone during gingival recession treatment.
Ethics approval(s)	Approved 31/08/2020, Scientific Research and Postgraduate Studies Council (Baramkeh, Damascus, Syria; +963 (0)1133923192; ap.srd@damascusuniversity.edu.sy), ref: 2400/S.M
Condition	Gingival recession
Intervention	Participants are randomised using a sealed envelope method. Two treatment methods will be compared, the first one will involve applying a free gingival graft alone on the root surface (control group), while the second will involve applying injectable platelet-rich fibrin (i-PRF) to a root surface before applying a free gingival graft (experimental group). Participants are followed up at 1, 3 and 6 months.
Intervention type	Procedure/Surgery
Primary outcome measure	1. Gingival recession depth measured using a UNC-15 probe at baseline, 1, 3, 6 months 2. Gingival recession width measured using a UNC-15 probe at baseline, 1, 3, 6 months
Secondary outcome measures	1. Probing depth measured using a UNC-15 probe at baseline, 1, 3, 6 months 2. Clinical attachment level measured using a UNC-15 probe at baseline, 1, 3, 6 months 3. Keratinized tissue height measured using a UNC-15 probe at baseline, 1, 3, 6 months 4. Healing measured using a healing index at 1, 2 weeks and 1 month after surgery 5. Pain measured using a visual analogue scale (VAS) at 1 week after surgery 6. Bleeding measured using a visual analogue scale (VAS) at 1 week after surgery 7. Dentine hypersensitivity measured using a visual analogue scale (VAS) at baseline, 1, 3, 6 months
Overall study start date	30/05/2020
Overall study end date	01/07/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	42 sites (21 for each group)
Participant inclusion criteria	1. ≥19 years of age 2. Periodontally and systemically healthy 3. Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) <15% 4. Presence of deep Miller Class I/II GR defect (≥3 mm in depth) at the buccal aspect of incisors and canines
Participant exclusion criteria	1. Smoking 2. Contraindications for surgery 3. Presence of recession defects associated with caries, deep abrasion, restoration or pulpal pathology
Recruitment start date	30/03/2021
Recruitment end date	31/12/2021

Locations

Countries of recruitment

Syria

Study participating centre

Damascus University

Department of Periodontology
Faculty of Dentistry
Mezzah
Damascus
00000
Syria

Sponsor information

Damascus University
University/education

Albaramkeh
Damascus
00000
Syria

Phone	+963 (0)1133923192
Email	info@damascusuniversity.edu.sy
Website	http://damasuniv.edu.sy/
"ROR"	https://ror.org/03m098d13

Funders

Funder type

University/education

Damascus University

No information available

Results and Publications

Intention to publish date	01/07/2023
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. Additional documents (such as study protocol, statistical analysis plan etc) will be available.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Dr Tarik Kasem (prof.tarekkasem@hotmail.com).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		11/05/2023	09/07/2024	Yes	No

Editorial Notes

09/07/2024: Publication reference added.
13/05/2021: Trial's existence confirmed by Damascus University.