Management of receding gums using tissue obtained from the roof of the mouth, a comparison of two techniques
| ISRCTN | ISRCTN35722376 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35722376 |
| Secondary identifying numbers | Approval of Dentistry college council- damascus university no. 677 date 28/5/2019 |
- Submission date
- 31/12/2019
- Registration date
- 14/01/2020
- Last edited
- 16/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Gingival recession, also known as receding gums, is the exposure in the roots of the teeth caused by a loss of gum tissue and/or retraction of the gum from the teeth. The usual treatment is to firstly graft tissue obtained from the roof of the mouth (palate) to make the loss area more resistant to recession (known as a free gingival graft) , the second stage after about three months includes another graft obtained from the deeper tissue of the palate to cover the loss (connective tissue graft).
This study will investigate the use of a newly developed technique that combines the two stages into one, combining the two tissue grafts before attaching to the gum area.
Who can participate?
Adults aged 18 – 55 years with gingival recession on both sides of the mouth
What does the study involve?
Participants will have on side of their mouth treated with the usual method, and the other side of the mouth treated with the new method. Participants will not know which treatment is being used on which side of the mouth.
What are the possible benefits and risks of participating?
The main benefit of enrolling the trial is getting stronger gums in the affected areas and getting rid of gums receding by covering the root's exposure by the grafts.
There is one risk could occur; the graft may fail to integrate with receiving area; if that happened, the receding gums would return to its primary shape before surgery and the patient may have a little bit of pain and malaise.
Where is the study run from?
Damascus University, Dentistry College, Department of Periodontology, Syria
When is the study starting and how long is it expected to run for?
January 2020 to June 2021
Who is funding the study?
Damascus University, Syria
Who is the main contact?
Dr Jihad Al-Rashed
dr.j.r.tsm@gmail.com
Contact information
Scientific
Mazzeh Highway
Almohafaza building no.6
Damascus
00000
Syria
 ORCID ID |
0000-0002-3368-9022 |
|---|---|
| Phone | +963 933663884 |
| dr.j.r.tsm@gmail.com |
Study information
| Study design | Current study design as of 18/02/2020: Single-centre single-blind randomized trial with split-mouth technique _____ Previous study design: Single-centre single-blind randomized controlled trial with split-mouth technique |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Management of gingival recession of Miller's class ǁ using two techniques: Combined Gingival Graft (FGG + CTG) and Free Gingival Graft |
| Study acronym | CGG |
| Study objectives | There are statistical differences in the averages of the studied variables between the two surgical procedures at the end of every period of follow-up periods. |
| Ethics approval(s) | Approved 08/07/2019, Ethics Committee - Dental College - Damascus University (Mazzeh Highway, Damascus, Syria; +963 1133923486; sr.srd@damasuniv.edu.sy), ref: no.3518 |
| Health condition(s) or problem(s) studied | Gingival recession of Miller's class II |
| Intervention | This study will try a new surgical technique to cover Miller's class II gingival recession. Those patients are usually treated by free gingival graft harvested of the palate to increase attached gingiva width and after 3 months if the result is not as desirable they would undergo second surgical procedure including harvesting connective tissue graft from the palate to cover the entire recession simultaneously with coronally advanced flap. The present study will integrate the two procedures in one surgical procedure and confirm the desirable last result from the first hour after surgery. The new technique depends on harvesting full-thickness graft from the palate and de-epithelializing a part of it and removing the connective tissue from the second part; this way one graft includes free gingival graft and connective tissue graft connected together. Participants will receive the traditional technique (free gingival graft) for one side of the mouth (control sample) and the newly described technique for the other side. The total duration of treatment and follow-up for all the study arms is 8 months. Randomization method; throwing a dice, if less than or equal to 3, the right side of patient's mouth will be treated by the new technique (combined gingival graft), if greater than 3, the right side will be treated by traditional technique (free gingival graft). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Current primary outcome measure as of 18/02/2020: 1. Gingival recession measured by periodontal probe from a stable point (acrylic splint made for each patient) to the gingival margin at three time points: date of surgery, after one month, and after 3 months) 2. Width of attached gingiva measured by periodontal probe at three time points: date of surgery, after one month, and after 3 months _____ Previous primary outcome measure: 1. Gingival recession measured by periodontal probe from a stable point (acrylic splint made for each patient) to the bottom of gingival sulcus at three time points: date of surgery, after one month, and after 3 months 2. Width of attached gingiva measured by periodontal probe at three time points: date of surgery, after one month, and after 3 months |
| Secondary outcome measures | Gingival Biotype (the thickness of gingiva) measured by periodontal probe at three time points: date of surgery, after one month, and after 3 months |
| Overall study start date | 15/01/2020 |
| Completion date | 05/06/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 10 patients (twenty surgical sites) |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. Age between 18 - 55 years 2. There is no systematic disease that affects the wound healing 3. Good oral hygiene with no symptoms of gingivitis 4. No smoking habit 5. Gingival recession of Miller's class II on two sides of the mouth 6. No previous periodontal surgery in the targeted area |
| Key exclusion criteria | 1. Systemic disease that affects wound healing. 2. Gingival or periodontal disease 3. Uncontrolled plaque accumulation 4. Pregnancy and breast-feeding 6. Previous periodontal surgery in the targeted area |
| Date of first enrolment | 20/01/2020 |
| Date of final enrolment | 27/02/2021 |
Locations
Countries of recruitment
- Syria
Study participating centre
Mazzeh Highway
Damascus
DM20AM18
Syria
Sponsor information
University/education
Dental College
Mazzeh Highway
Damascus
00000
Syria
| Phone | +963 112121635 |
|---|---|
| info@damascusuniversity.edu.sy | |
| Website | http://www.damascusuniversity.edu.sy/dent/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 20/08/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned to be published in Periodontology 2000 Journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Editorial Notes
16/04/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/03/2021 and 27/02/2021.
2. The overall trial end date has been changed from 20/06/2021 to 05/06/2021.
3. The total final enrolment number has been added.
16/02/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/04/2020 to 30/03/2021.
2. The overall trial end date has been changed from 15/08/2020 to 20/06/2021 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 15/11/2020 to 20/08/2021.
18/02/2020: The following changes were made to the trial record:
1. The study design
2. The primary outcome measure
14/01/2020: Trial’s existence confirmed by Damascus University
