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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Damascus University |
| Funder | Damascus University |
- 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
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
Public, Scientific, Principal investigator
Dumar
Damascus
-
Syria
| Phone | +963(0)951753797 |
|---|---|
| rymazoad@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Pain using the visual analogue scale (VAS) 0-100 at 1 week after surgery |
| Key secondary outcome measure(s) |
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 |
| Completion date | 09/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | All |
| Target sample size at registration | 20 |
| 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
-
Syria
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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.
