Condition category
Oral Health
Date applied
03/02/2020
Date assigned
07/02/2020
Last edited
07/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Gingival recession is a retraction of tissues which cover the teeth, this retraction causes aesthetic problems, teeth sensitivity and caries.
As usual we can solve this problem by a surgical procedure ( we extract a tissue from the roof of the mouth, it's name is a connective tissue graft ) by a traditional surgical tool by a traditional technique, but this approach may causes more pain and less satisfaction for the patient, a long time-surgery and longer time healing.
So in our study we will use a new tool with a new technique ( Double Bladed Scalpel ) to obtain better tissue from the roof of the mouth to improve our results and to make our patient more satisfied at all levels.

Who can participate?
Adults aged 18 – 55 years with gum tissues retraction on both sides of the jaw.

What does the study involve?
Participants who will be treated by a traditional tool and a traditional approach on one side of their jaw while they will be treated by a new tool on their other side of the jaw. 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 is a root coverage and an aesthetic aspect improvement.
the possible risk is a graft failure caused by lack of maintenance of the patient so the receding gum will return to its primary shape before surgery

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?
February 2020 to September 2020

Who is funding the study?
Damascus University, Syria

Who is the main contact?
Dr Laura Mrhej
lauramrhej@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Laura Mrhej

ORCID ID

https://orcid.org/0000-0002-7210-4998

Contact details

Damascus University
Mazzeh HIghway
Damascus
-
Syria
+963 993422870
lauramrhej@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Approval of Dentistry College Council- Damascus University no. 686 date 18/06/2019

Study information

Scientific title

Connective tissue graft harvesting with double bladed scalpel and traditional scalpel for treatment of gingival recession. a comparative randomized clinical trial

Acronym

CTG

Study hypothesis

There are statistical differences in the averages of the studied variables between the two surgical procedures at the end of the follow-up period.

Ethics approval

Approved 05/08/2019, Ethics Committee- Dental College- Damascus University (Mazzeh Highway, Damascus, Syria; +963 1133923486; sr.srd@damasuniv.edu.sy), ref: no.3889

Study design

Single-center single-blind comparative randomized clinical 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 I

Intervention

This study will compare between two scalpels to harvest a connective tissue graft for treatment of gingival recession.

The first one will be used in (test group) is double bladed scalpel (5 DOUBLE-BLADED SCALPEL HANDLE, 1MM, 1013005D1, Hu-Freidy). The handle of this scalpel holds two blades with a 1mm separation between them, this will provide me with a graft slightly thicker of around 1.2-1.5 mm after harvesting. After anesthetizing the area, we will make a horizontal incision 2.5 mm apical to gingival margins of the teeth with a 15 or 15c bard parker blade then we will Elevate a short full thickness flap of 3 mm to 4 mm approximately in order to allow exposure of the connective tissue area apical to the incision and insert the double blade knife mounted with two bard parker 15 blades (not the 15c blades!- they are too thin and will bend) into the thickness of the detached palatal flap at its distal end. After that we will take them to the desired apicoronal depth, and then move slowly towards the mesial. In the end we will Cut the perimeter of the graft with a mesial and a distal vertical incision, and a horizontal apical incision aimed to bony surface will be made to liberate the graft.
This technique will consistently provide a graft of predetermined and uniform thickness that will help me to decide the size, thickness, and composition of the graft we desire, and harvest it accordingly.

In control group, we will use a traditional scalpel to harvest the graft with (single incision technique) : The anterior and posterior borders of this rectangle will be located in the canine region and at the palatal root of the first molar. Incision will be made at a 90-degree angle to the bone. 2 mm away from the gingival margin then we will change it to 135 degrees to prepare a partial thickness flap towards the median, then we will use a periosteal elevator to detach the graft from the bone surface. In the end we will extract it by a mesial, distal and median incisions.

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 (the double bladed scalpel), if greater than 3, the right side will be treated by the traditional technique (the traditional scalpel).

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

1. Recession Depth (RD): is measured by a UNC15 periodontal probe from a stable point (acrylic splint made for each patient) to the gingival margin at two time points: date of surgery, and after three months
2. Gingival Width (GW) :is measured by a UNC15 periodontal probe at two time points: date of surgery, and after three months

Secondary outcome measures

1. Gingival Thickness (GT) : is measured by a UNC15 periodontal probe at two time points: date of surgery, and after three months
2. Clinical Attachement Level ( CAL) : is measured by a UNC periodontal probe from a stable point ( acrylic splint ) to the bottom of the gingival sulcus

Overall trial start date

01/02/2020

Overall trial end date

01/09/2020

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. Bilateral side of gingival recession ( Miller's class I )
6. At least 1mm of attached gingiva.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10 patients (twenty surgical sites)

Participant exclusion criteria

1. Systemic disease or medication that affects wound healing
2. Gingival or periodontal disease or uncontrolled plaque accumulation
3. Pregnancy and breast-feeding

Recruitment start date

06/02/2020

Recruitment end date

06/05/2020

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

Mazzeh Highway
Damascus
DM20AM18
Syria
+963 112121635
info@damascusuniversity.edu.sy

Sponsor type

University/education

Website

http://damasuniv.edu.sy/

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

15/12/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/02/2020: Trial’s existence confirmed by Damascus University.