Semilunar and Conventional Coronally Positioned Flap for the Treatment Gingival Recession

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03391947
• Date of registration: 31/12/2017
• Prospective Registration: No
• Primary sponsor: Damascus University
• Public title: Semilunar and Conventional Coronally Positioned Flap for the Treatment Gingival Recession
• Scientific title: Comparison of a Semilunar Coronally Positioned Flap and Conventional Coronally Advanced Flap for the Treatment of Gingival Recession- A Split-mouth, Randomized Prospective Comparative Controlled Clinical Trial
• Date of first enrolment: December 1, 2017
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03391947
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Syrian Arab Republic

Contacts

• Name: Hala Mohammad Walid Hala Mohammad Walid, DDS
• Affiliation: MSc student in Periodontics, Periodontology Department, University of Damascus Dental School

• Name: Suleiman Dayoub, DDS MSc PhD
• Affiliation: Professor of Periodontics, Department of Periodontology, University of Damascus Dental School

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients are in general good health.

- The patient is non-smoker (less than 10 cigarettes per day) and non-alcoholic.

- Female participants must not be pregnant and not at menstrual period during surgery.

- The patient is committed to the oral care, and has a healthy periodontium.

- Absence of severe oral habits.

- They have not taken medication known to interfere with periodontal tissue health or
healing in the preceding 6 months.

- Presence of bilateral buccal Miller class I gingival recessions (=5 mm) in maxillary
incisors, canines, or premolars.

- Presence width of keratinized tissue (WKT) =2 mm.

- The tooth is vital and absence of caries or restorations in the areas that will be
treated.

- Pocket depth less than 3 mm without bleeding on probing (BOP).

Exclusion Criteria:

1. Patients less than 18 years old

2. Patients with untreated periodontal disease.

3. Smokers.

4. Immunosuppressive systemic diseases (like cancer, AIDS, diabetes…)

5. Miller's class II, III or IV gingival recession defects.

6. Presence of apical radiolucency or root surface restoration or caries at the defect
site

7. Medications influence on the health of the gingival tissue (like calcium channel
blockers, immunosuppressive systemic diseases (like cancer, AIDS, diabetes…) or
Long-term steroid use



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Root Coverage

Gingival Recession

Intervention(s)

Procedure: coronally advanced flap

Procedure: semilunar coronally positioned flap

Primary Outcome(s)

Change in the amount of root coverage [Time Frame: (1) one day before the surgery, (2) at 2 weeks post-surgery, (3) at 1 month post-surgery, (4) and at 3 months post-surgery]

Secondary Outcome(s)

Change in root sensitivity [Time Frame: (1) one day before the surgery, (2) at 2 weeks post-surgery, (3) at 1 month post-surgery, (4) and at 3 months post-surgery]

Change in the position of the mucogingival junction [Time Frame: (1) one day before the surgery, (2) at 2 weeks post-surgery, (3) at 1 month post-surgery, (4) and at 3 months post-surgery]

Change in the clinical attachment level [Time Frame: (1) one day before the surgery, (2) and at 3 months post-surgery]

Patients' satisfaction with aesthetics [Time Frame: at three months post-surgery]

Change in the width of keratinized tissue [Time Frame: (1) one day before the surgery, (2) at 2 weeks post-surgery, (3) at 1 month post-surgery, (4) and at 3 months post-surgery]

Change in the wound healing index [Time Frame: (1) at two weeks following surgery and (2) at one month following surgery.]

Change in the gingival recession width [Time Frame: (1) one day before the surgery, (2) at 2 weeks post-surgery, (3) at 1 month post-surgery, (4) and at 3 months post-surgery]

Change in sulcus bleeding index [Time Frame: (1) one day before the surgery, (2) and at 3 months post-surgery]

Change in the thickness of the keratinized tissue [Time Frame: (1) one day before the surgery, (2) and at 3 months post-surgery]

Change in post-operative pain level [Time Frame: at 2 hours, 24 hours, 48 hours, 72 hours following surgery and at 1-week after surgery]

Change in probing depth [Time Frame: (1) one day before the surgery, (2) and at 3 months post-surgery]

Change in visible plaque index [Time Frame: (1) one day before the surgery, (2) at 2 weeks post-surgery, (3) at 1 month post-surgery, (4) and at 3 months post-surgery]

Secondary ID(s)

UDDS-Perio-01-2018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors