Investigating how well a new type of covering for the gums, called periodontal dressing, helps in the healing of wounds on the roof of the mouth

ISRCTN	ISRCTN11471570
DOI	https://doi.org/10.1186/ISRCTN11471570

Submission date: 02/03/2024
Registration date: 11/03/2024
Last edited: 11/03/2024

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
Gingival recession also known as receding gums, is defined as the apical displacement of the gingival margin in relation to the cemanto-enamel junction (CEJ). the usage of connective tissue graft (CTG) with the Coronally Advanced Flap (CAF) is considered the gold standard for gingival recession and root coverage treatment. However, this technique requires a secondary surgical site, which can increase the postoperative pain.
The aim of this study is to evaluate the efficacy of using an attachable periodontal dressing (Ora_Aid) to protect the injury from mechanical harm, postoperative bleeding, or inflammation and to alleviate postoperative pain.

Who can participate?
Healthy adults aged 19 and over who are non-smokers.

What does the study involve?
Participants are randomly allocated to one of two treatment methods. One involves applying the gingival graft (CTG) with Coronally advanced flap (CAF), followed by applying the adhesive periodontal dressing on the donor site of the graft in the palatal area and over the flap. While the other involves applying (CAF) with (CTG) without applying dressing.

What are the possible benefits and risks of participants?
The possible benefits for participants are achieving less postoperative pain and better healing.
The methods are safe and there are no expected risks.

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

When is the study started and how long is it expected to run for?
May 2022 to December 2023

Who is funding the study?
Damascus University (Syria)

Who is the main contact?
Dr Remaz Abd Alkader, rymazoad@gmail.com

Contact information

Dr Remaz Abdalkader
Public, Scientific, Principal Investigator

Dumar
Damascus
-
Syria

Phone	+963(0)951753797
Email	rymazoad@gmail.com

Study information

Study design	Interventional randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	University/medical school/dental school
Study type	Treatment
Scientific title	Evaluation of the effect of attachable periodontal wound dressing (Ora-Aid) In the healing of the soft tissue during gingival recession treatment
Study objectives	The dressing is expected to alleviate the Patient's pain sensation and enhance the healing process of the palatal wound.
Ethics approval(s)	Approved 09/05/2022, Damascus university - faculty of dental medicine (Damascus-Almazah, Damascus, -, Syria; +963113341864; manger@hcsr.gov.sy), ref: 223445
Health condition(s) or problem(s) studied	Bilateral class I or II of Miller classification of gingival recession.
Intervention	Participants are randomly assigned using a sealed envelope method. Two treatment methods will be implemented. The first will involve applying a connective tissues graft (CTG) with a coronally advanced flap (CAF) and managing the donor site in the palatal by suturing, while the second will involve applying the connective tissue graft (GTG) with the Coronally advanced flap (CAF) with applying an adhesive periodontal dressing (Ora_Aid) on the donor site in palatal and over the Flap.
Intervention type	Procedure/Surgery
Primary outcome measure	1. Pain using the visual analogue scale (VAS) 0-100 at 1 week after surgery 2. Wound healing assessment (Landry et al., 1988) at 1,2,3,4 weeks after surgery
Secondary outcome measures	1. Keratinized tissue width measured from gingival margin to mucogingival junction with the help of periodontal probe (UNC 15 probe) at baseline 1 and 3 months 2. Epithelization test at baseline 1 and 3 months 3. Relative attachment level measured using (UNC 15 probe) at baseline 1 and 3 month 4. HEALING INDEX (Huang, Neiva, & Wang, 2005) at baseline 1 and 3 months
Overall study start date	09/05/2022
Completion date	09/12/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	50 Years
Sex	Both
Target number of participants	20 sites (10 for each group)
Key inclusion criteria	1. Good general health. 2. There are no contraindications to peridental surgery. 3. Complaint of receding gums at least in the upper jaw and/or mandible. 4. All Recessions of class \| OR \|\| Miller. 5. The appearance of the Cemantoenamel junction in the teeth that need to cover the root. 6. All patients achieve adequate control of the microbial plaque. 7. All patients are over 18 years old. 8. The patient has not been subjected to any surgery around the tooth in the area to be worked on
Key exclusion criteria	1. Previous periodontal surgery 2. Use of any drug that might affect periodontal health 3. Tooth mobility ,bruxism 4. Patients with a history of malignancy
Date of first enrolment	01/10/2022
Date of final enrolment	10/10/2023

Locations

Countries of recruitment

Syria

Study participating centre

Damascus university Department of periodontology faculty of dentistry

Mezzah
Damascus
-
Syria

Sponsor information

Damascus University
University/education

Albaramka
Damascus
-
Syria

Phone	+963(0)1133923192
Email	info@damascusuniversity.edu.sy
Website	https//damasuniv.edu.sy
"ROR"	https://ror.org/03m098d13

Funders

Funder type

University/education

Damascus University
Government organisation / Universities (academic only)

Alternative name(s): University of Damascus, جَامِعَةُ دِمَشْقَ, DU
Location: Syria

Results and Publications

Intention to publish date	31/12/2024
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 analyzed during the current study are/will be available upon request from prof. Dr Tarik Kasim (prof.tarekkasem@hotmail.com) All of data of the patients will be available on request. Consent from participant was obtained.

Editorial Notes

04/03/2024: Trial's existence confirmed by Damascus University.