Condition category
Oral Health
Date applied
31/12/2019
Date assigned
14/01/2020
Last edited
18/02/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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 August 2020

Who is funding the study?
Damascus University, Syria

Who is the main contact?
Dr Jihad Al-Rashed
dr.j.r.tsm@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jihad Al-Rashed

ORCID ID

http://orcid.org/0000-0002-3368-9022

Contact details

Mazzeh Highway
Almohafaza building no.6
Damascus
00000
Syria
+963 933663884
dr.j.r.tsm@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Approval of Dentistry college council- damascus university no. 677 date 28/5/2019

Study information

Scientific title

Management of gingival recession of Miller's class ǁ using two techniques: Combined Gingival Graft (FGG + CTG) and Free Gingival Graft

Acronym

CGG

Study hypothesis

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

Approved 08/07/2019, Ethics Committee - Dental College - Damascus University (Mazzeh Highway, Damascus, Syria; +963 1133923486; sr.srd@damasuniv.edu.sy), ref: no.3518

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

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 trial start date

15/01/2020

Overall trial end date

15/08/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10 patients (twenty surgical sites)

Participant 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

Recruitment start date

20/01/2020

Recruitment end date

30/04/2020

Locations

Countries of recruitment

Syria

Trial participating centre

Damascus University
Dentistry College, Department of Periodontology Mazzeh Highway
Damascus
DM20AM18
Syria

Sponsor information

Organisation

Damascus University

Sponsor details

Dental College
Mazzeh Highway
Damascus
00000
Syria
+963 112121635
info@damascusuniversity.edu.sy

Sponsor type

University/education

Website

http://www.damascusuniversity.edu.sy/dent/

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 to be published in Periodontology 2000 Journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

15/11/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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