A new material for treatment of single receding gums
| ISRCTN | ISRCTN15571664 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15571664 |
| Secondary identifying numbers | 2508/S.M |
- Submission date
- 13/01/2022
- Registration date
- 24/01/2022
- Last edited
- 12/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Receding gums (also known as gingival recession) 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 increase root coverage and soft tissue thickness using different treatment methods.
Who can participate?
Healthy adults aged 18 years or older and with no contraindications to surgical intervention.
What does the study involve?
Participants are randomly allocated to one of two treatment methods, one will involve Xenogeneic dermal matrix (Mucoderm) with coronal advanced flap, while the other involves subepithelial connective tissue graft with coronal advanced flap for treatment of Miller type I, II gingival recession. Participants are followed up to measure gingival recession and soft tissue thickness at 3 and 6 months.
What are the possible benefits and risks of participating?
The benefit is proven the effectiveness of full coverage of the roots and an increase in the thickness of the keratinized gingiva by applying Xenogeneic dermal matrix (Mucoderm), as similar as to subepithelial connective tissue graft. 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?
March 2021 to April 2023
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Mohammad Alabed
alabod010@gmail.com
Contact information
Scientific
Mazzeh
Damascus
-
Syria
 ORCID ID |
0000-0001-9514-1989 |
|---|---|
| Phone | +963 969892003 |
| alabod010@gmail.com |
Study information
| Study design | Split-mouth interventional double-blinded randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Clinical comparison of coronally-advanced flap plus Xenogeneic Porcine-derived acellular dermal Matrix (Botiss Mucoderm®) and subepithelial connective tissue graft in the treatment of single tooth recessions |
| Study objectives | There is no difference between Mucoderm and subepithelial connective tissue graft for root coverage and increased soft tissue thickness. |
| Ethics approval(s) | Approved 02/08/2021, Scientific Research and Postgraduate Studies Council (Baramkeh, Damascus, Syria +963 1133923192; ap.srd@damascusuniversity.edu.sy), ref: 2508/S.M |
| Health condition(s) or problem(s) studied | Gingival recession |
| Intervention | Participants defects will be randomly divided into two groups by obaque sealed invelope method: control group (will be treated with Coronal Advanced Flap (CAF) + subepithelial Connective Tissue Graft (sCTG) and test group (will be treated with Coronal Advanced Flap (CAF) + Xenogeneic Dermal Matrex Mucoderm (XDM). Participants are followed up at 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 3. Keratinized Tissue Thickness measured using an anesthesia needle attached to a silicone disc stop at base line, 3 , 6 months. |
| Secondary outcome measures | 1. Probing depth measured using a UNC-15 probe at baseline, 3, 6 months 2. Relative attachment level measured using a UNC-15 probe at baseline, 3, 6 months 3. Keratinized tissue height measured using a UNC-15 probe at baseline, 3, 6 months 4. Healing measured using a healing index at 1, 2 weeks and 1 month after surgery 5. Plaque presence measured using a plaque index at baseline, 1, 3, 6, months 6. Pain measured using a visual analogue scale (VAS) at 1 week after surgery 7. Bleeding measured using a visual analogue scale (VAS) at 1 week after surgery 8. Dentine hypersensitivity measured using a visual analogue scale (VAS) at baseline, 1, 3, 6 months |
| Overall study start date | 10/03/2021 |
| Completion date | 01/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 sites (15 for each group) |
| Key inclusion criteria | 1. Good general health. 2. No contraindications for periodontal surgery. 3. Presence one localized gingival recession in each side of the maxilla and/or mandible, All recessions will be Class I or II defects (Miller 1985). 4. The cemento–enamel junction (CEJ) will be visible in the teeth for root coverage procedures. 5. All patients demonstrating adequate plaque control. 6. All patients will be at least 18 years of age. 7. No previous periodontal surgery in the area. |
| Key exclusion criteria | 1. Patients smoking more than 10 cigarettes per day. 2. Patients with insulin-dependent diabetes. 3. Patients with a history of malignancy, radiotherapy, or chemotherapy for malignancy. 4. Patient pregnant or nursing during the past 5 months. 5. Patients taking medications or having treatments with an effect on mucosal healing in general (e.g. steroids, large doses of anti inflammatory drugs). 6. Patients with a disease affecting connective tissue metabolism. 7. Patients allergic to collagen. 8. Presence more than one localized gingival recession in each side of the maxilla and/or mandible. |
| Date of first enrolment | 01/09/2021 |
| Date of final enrolment | 01/06/2022 |
Locations
Countries of recruitment
- Syria
Study participating centre
Faculty of Dentistry
Damascus
-
Syria
Sponsor information
University/education
Albaramkeh
Damascus
-
Syria
| Phone | +963 1133923192 |
|---|---|
| info@damascusuniversity.edu.sy | |
| Website | http://damasuniv.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 01/06/2023 |
|---|---|
| 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, statical 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. Suleiman Dayoub suleimandayoub@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 24/01/2022 | No | No | ||
| Results article | 12/07/2024 | 12/03/2025 | Yes | No |
Additional files
Editorial Notes
12/03/2025: Publication reference added.
30/12/2022: The following changes have been made:
1. The overall trial end date has been changed from 01/01/2023 to 01/04/2023 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 01/11/2022 to 01/06/2023.
24/01/2022: Trial's existence confirmed by Damascus University.
