Condition category
Oral Health
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
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

Trial website

Contact information



Primary contact

Dr Jihad Al-Rashed


Contact details

Mazzeh Highway
Almohafaza building no.6
+963 933663884

Additional identifiers

EudraCT number

Nil known 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



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;, 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


Secondary study design

Randomised parallel trial

Trial setting


Trial type


Patient information sheet

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


Gingival recession of Miller's class II


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



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment


Trial participating centre

Damascus University
Dentistry College, Department of Periodontology Mazzeh Highway

Sponsor information


Damascus University

Sponsor details

Dental College
Mazzeh Highway
+963 112121635

Sponsor type




Funder type


Funder name

Damascus University

Alternative name(s)

Funding Body Type

Funding Body Subtype


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


Participant level data


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