A study of the gums and orthodontic tooth movement after a connective tissue graft

ISRCTN	ISRCTN42398071
DOI	https://doi.org/10.1186/ISRCTN42398071
Secondary identifying numbers	M.S /513/

Submission date: 16/07/2022
Registration date: 02/08/2022
Last edited: 02/08/2022

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This study aims to measure the effects of using connective tissue grafts on orthodontic patients (with crowding in the lower front teeth) with a thin gingival (gum) biotype at risk of periodontal (gum) problems, compared to patients receiving only orthodontic treatment.

Who can participate?
Patients aged 15-40 years who want to align their teeth with orthodontic treatment and have a thin gingival biotype

What does the study involve?
Participants are randomly allocated to be treated with a connective tissue graft and orthodontic treatment (the experimental group) or orthodontic treatment only (the observational group).

What are the possible benefits and risks of participating?
Participants may benefit from increased gingival thickness and width of attached gingiva and faster orthodontic movement. The procedure doesn't involve any risks. It may prevent gingival problems during orthodontic treatment in patients with a thin gingival biotype.

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

When is the study starting and how long is it expected to run for?
May 2021 to December 2022

Who is funding the study?
Tishreen University (Syria)

Who is the main contact?
Dr Mai Souliman, maisouliman001@gmail.com

Contact information

Dr Mai Souliman
Principal Investigator

Abo- Rammaneh, next to Saudi Arabia Embassy
Damascus
-
Syria

Phone	+963 (0)932226230
Email	maisouliman001@gmail.com

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a participant information sheet
Scientific title	A study of gingival parameters and acceleration of orthodontic movement after implementation of connective tissue graft using the tunnel technique on patients with crowding in the lower anterior teeth and thin gingival biotype
Study objectives	The aim is to study gingival parameters and acceleration of orthodontic movement after implementation of connective tissue graft using the tunnel technique on patients with crowding in the lower anterior teeth and thin gingival biotype
Ethics approval(s)	Approved 27/09/2021, Damascus University Rector (Baramkeh, Damascus, Syria; +966 (0)55 506 3806; email: not available), ref: 3391 MS
Health condition(s) or problem(s) studied	Gingival diseases in patients with thin gingival biotype and treated by orthodontics
Intervention	This study is a randomized controlled trial. Patients are randomly selected according to their order of arrival, and the odd numbers are only treated by orthodontics. The even numbers have braces installed then the connective tissue graft (tunnel technique) will be performed. After 1 week the suture will be removed and the wire added to start the orthodontic treatment. The duration of treatment is 2-3 weeks (to test and select the appropriate patient, set up the braces then implement the connective tissue graft) and the follow-up is during the orthodontic treatment which ranges between 4-6 months.
Intervention type	Procedure/Surgery
Primary outcome measure	1. Acceleration of the orthodontal movement assessed by Little's irregularity index before and every month after the connective tissue graft until the end of the orthodontic treatment 2. Gingival thickness assessed by an endodontic spreader before and after the treatment 3. Width of the attached gingiva assessed by William's prober before and after the treatment
Secondary outcome measures	Gingival parameters measured using the root coverage esthetic score (RES) before and after the treatment: 1. GM (gingival margin): zero points = failure of root coverage (gingival margin apical or equal to the baseline recession); 3 points = partial root coverage; 6 points = complete root cover 2. MTC (marginal tissue contour): zero points = irregular gingival margin (does not follow the CEJ); 1 point = proper marginal contour/scalloped gingival margin (follows the CEJ) 3. STT (soft tissue texture): zero points = scar formation and/or keloid-like appearance; 1 point = absence of scar or keloid formation 4. MGJ (mucogingival junction): zero points = MGJ not aligned with the MGJ of adjacent teeth; 1 point = MGJ aligned with the MGJ of adjacent teeth
Overall study start date	14/05/2021
Completion date	01/12/2022

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	Both
Target number of participants	The target number of participants will be determined after finishing the pilot study (5 patients) using the G power program. It is expected to be 20 patients (10 for the experimental cluster and 10 for the observational cluster).
Key inclusion criteria	1. Aged between 15-40 years old 2. Crowding in the lower anterior teeth (4-6 mm) 3. Thin gingival biotype (less than 1 mm) 4. Non-smoking 5. No general diseases 6. Good oral hygiene 7. No problem with gingival recession
Key exclusion criteria	1. Children (under 15 years old) and old age 2. Crowding in the lower anterior teeth (more than 6 mm) 3. Thick gingival biotype 4. Smoking 5. General diseases 6. Bad oral hygiene 7. Periodontitis
Date of first enrolment	05/11/2021
Date of final enrolment	31/08/2022

Locations

Countries of recruitment

Syria

Study participating centre

Damascus University

Periodontology Department
Faculty of Dentistry
Mazzeh Highway
Damascus
-
Syria

Sponsor information

Tishreen University
University/education

Lattakia
Latakia
-
Syria

Phone	+963 (0)11 33923192
Email	president@tishreen.edu.sy
Website	http://en.tishreen.edu.sy/
"ROR"	https://ror.org/04nqts970

Funders

Funder type

University/education

Tishreen University
Government organisation / Universities (academic only)

Alternative name(s): October University, Université Tichrine, جامعة تشرين, TU
Location: Syria

Results and Publications

Intention to publish date	30/12/2023
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
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Mai Eissa Souliman (maisouliman001@gmail.com). The data will become available in 2023.

Editorial Notes

01/08/2022: Trial's existence confirmed by the Damascus University Rector.