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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Damascus University
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Change in the amount of root coverage
Study Overview
Brief Summary
A clinical evaluation of using the semilunar coronally position flap (SCPF) compared to the conventional coronally advanced flap (CAF) with modification to treat class I Miller gingival recession. The coronally repositioned gingival margin will be stabilized by coronally anchored suture with composite stops on the buccal surface of the tooth using flowable composite. The sample size will be ten patients. Each patient has bilateral Miller Class I gingival recessions; one will be treated with SCPF, while the other will be treated with CAF
Detailed Description
The aim of this study is to clinically compare between the semilunar coronally positioned flap (SCPF) and the conventional coronally advanced flap (CAF) after applying modification in both techniques to treat class I Miller gingival recession. Coronally repositioned gingival margin will be stabilized by coronally anchored suture with composite stops on the buccal surface of tooth using flowable composite for the treatment of gingival recession. Ten patients who have bilateral maxillary buccal Miller Class I gingival recession defects will be enrolled in this study. These defects will be distributed randomly into two groups: the test group (SCPF) and control group (CAF). Clinical parameters will be evaluated: visible plaque index (VPI), sulcus bleeding index (SBI), probing depth (PD), gingival recession height (GRH), gingival recession width (GRW), clinical attachment level (CAL), width of keratinized tissue (WKT), thickness of keratinized tissue (TKT), change in the position of muco-gingival junction, vestibular depth, wound healing index (WHI), the percentage of root coverage (RC) and root coverage esthetic score (RES) system. A questionnaire will be given to each patient, which includes evaluation of the pain intensity, root sensitivity, and satisfaction with aesthetic by using the visual analog scale (VAS) and questions about the number of analgesic pills consumed per day.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Patients less than 18 years old
- •Patients with untreated periodontal disease.
- •Immunosuppressive systemic diseases (like cancer, AIDS, diabetes...)
- •Miller's class II, III or IV gingival recession defects.
- •Presence of apical radiolucency or root surface restoration or caries at the defect site
- •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
Arms & Interventions
semilunar coronally positioned flap
A semilunar incision will be done following the curvature of the gingival margin and ending about 2 to 3 mm short of the tip of the papillae. The most apical distance of this incision to the gingival margin will be obtained by adding the bone sounding measurement to the recession height. Perform a split-thickness dissection coronally from the incision, and connect it to an intrasulcular incision. The tissue will be collapsed coronally, covering the denuded root. The coronally repositioned gingival margin will be stabilized by coronally anchored suture with composite stops on the buccal surface of the tooth using flowable composite. Finally, the area will be covered with a periodontal dressing. This is called semilunar coronally positioned flap.
Intervention: semilunar coronally positioned flap (Procedure)
coronally advanced flap
Coronally positioned flap will be initiated with two vertical incisions, extending from a mesial and distal linear angle at the cementoenamel junction (CEJ) and go beyond the mucogingival junction. A split thickness flap will be prepared by sharp dissection mesial and distal to the recession and connected with an intra crevicular incision. On the facial aspect of the tooth, a full thickness flap, approximately 3-4 mm apical to crest of alveolar bone. Then, the flap will be returned and sutured it at 1 mm coronal to the CEJ after de-epithelize the papillae. The coronally repositioned gingival margin will be stabilized by coronally anchored suture with composite stops on the buccal surface of the tooth using flowable composite and sutured in the papilla region and releasing incision. Finally, the area will be covered with a periodontal dressing.
Intervention: coronally advanced flap (Procedure)
Outcomes
Primary Outcomes
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
this will be measured as a change of gingival recession height GRH (the distance from the cemento-enamel junction CEJ to the gingival margin GM by using an endodontic finger spreader attached to a rubber stopper and after removing the spreader, penetration depth was measured with a caliper of 0.01-mm resolution) from baseline and follow-up period.
Secondary Outcomes
- Change in the clinical attachment level((1) one day before the surgery, (2) and at 3 months post-surgery)
- Change in the gingival recession width((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 thickness of the keratinized tissue((1) one day before the surgery, (2) and at 3 months post-surgery)
- Change in root sensitivity((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((1) one day before the surgery, (2) and at 3 months post-surgery)
- Change in the width of keratinized tissue((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((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)
- Patients' satisfaction with aesthetics(at three months post-surgery)
- Change in post-operative pain level(at 2 hours, 24 hours, 48 hours, 72 hours following surgery and at 1-week after surgery)
- Change in visible plaque index((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 probing depth((1) one day before the surgery, (2) and at 3 months post-surgery)
- Change in the wound healing index((1) at two weeks following surgery and (2) at one month following surgery.)