An interventional study of semilunar coronally positioned flap and coronally advanced flap in Gingival Recession and Root Coverage, sponsored by Damascus University. Completed at 1 site in Syria. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-07-18.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
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
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.
413 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.
This study's enrollment of 10 is below the median of 30 across 379 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →Damascus University is the lead sponsor of 210 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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.
Procedure: semilunar coronally positioned 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.
Procedure: coronally advanced flap
The description of this intervention has been already given before
The description of this intervention has been already given before
Change in the amount of root coverage
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.
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 visible plaque index
Score 0 - No plaque Score 1 - Separate flecks of plaque at the cervical margin of the tooth Score 2 - A thin continuous band of plaque at the cervical margin of the tooth Score 3 - A band of plaque wider then 1mm covering less than 1/3rd of the crown of the tooth Score 4 - Plaque covering at least 1/3rd but less than 2/3rd of the crown of the tooth Score 5 - Plaque covering 2/3rd or more of the crown of the tooth
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
will be evaluated visually (using an UNC-15 mm "University of North Carolina" periodontal probe) Score 0 - health looking papillary and marginal gingiva no bleeding on probing; Score 1 - healthy looking gingiva, bleeding on probing; Score 2 - bleeding on probing, change in color, no edema; Score 3 - bleeding on probing, change in color, slight edema; Score 4 -bleeding on probing, change in color, obvious edema; Score 5 -spontaneous bleeding, change in color, marked edema
Time frame: (1) one day before the surgery, (2) and at 3 months post-surgery
Change in probing depth
Probing depth will be measured as the distance from the gingival margin GM to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina") with a rubber stopper.
Time frame: (1) one day before the surgery, (2) and at 3 months post-surgery
Change in the clinical attachment level
clinical attachment level will be calculated as the sum of the gingival recession height and the probing depth (mentioned above).
Time frame: (1) one day before the surgery, (2) and at 3 months post-surgery
Change in the gingival recession width
Gingival recession width will be measured from one border of the recession to another at the CEJ 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
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 width of keratinized tissue
The width of the keratinized tissue will be measured as the distance between the most apical point of the GM and the MGJ 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.
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 thickness of the keratinized tissue
Time frame: (1) one day before the surgery, (2) and at 3 months post-surgery
Change in the position of the mucogingival junction
The distance between the incisal edge and the mucogingival junction will be measured 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
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
Wound healing index will be recorded after surgery using the following criteria: score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration
Time frame: (1) at two weeks following surgery and (2) at one month following surgery.
Change in post-operative pain level
Using a 10 cm-visual analog scale
Time frame: at 2 hours, 24 hours, 48 hours, 72 hours following surgery and at 1-week after surgery
Patients' satisfaction with aesthetics
Using a 10 cm-visual analog scale (VAS), patients' satisfaction with the aesthetic result will be recorded with 0 indicating very bad, 5 indicating average feelings and 10 indicating excellent result.
Time frame: at three months post-surgery
Change in root sensitivity
Using a 10 cm-visual analog scale (VAS), patients' perception of root sensitivity will be recorded with zero indicating no pain or sensitivity, 5 indicating moderate pain or sensitivity and 10 indicating worst pain or sensitivity possible.
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
Plan to share: No
Ran from Dec 2017 to primary completion in Aug 2018, 8 months.
Of 229 non-industry interventional studies with no phase under Gingival Recession, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's 8 months is below that.
Counting every sponsor, half of 231 studies reached it within 19 months; a quarter within 11 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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