The present study is a human, prospective, single centre, single blind, comparative controlled randomized clinical trial for the treatment of Miller's Class I, II or combination of class I and II mandibular recession and comparing the clinical outcomes prior to and 6 months after treatment. The trial is in accordance to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
24 recession defects were selected in patients who were systemically and periodontally healthy, satisfying the determined inclusion criteria. Patients with at least two or more teeth having Miller's class I , II or combination of class I and II mandibular recession defects were included in the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, surgical procedure involved, potential benefits and risks associated with the surgical procedure and a written informed consent was obtained from all patients. The patients were assigned into two treatment groups (test and control). The test group was treated with recombinant human Platelet Derived Growth Factor-BB and Modified Coronally Advanced Tunnel +Connective Tissue Graft whereas the control group was treated by Modified Coronally Advanced Tunnel +Connective Tissue Graft alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
6
recession coverage is treated with modified coronally advanced tunnel with connective tissue graft with recombinant human platelet derived growth factor- BB for Experimental: Test group and without recombinant human platelet derived growth factor- BB for Active Comparator: Control group
Gingival recession depth (GRD)
measured as the distance from the Cemento Enamel Junction to the gingival margin
Time frame: 6 months
2. Gingival Recession Width (GRW)
measured as the distance between the mesial gingival margin and distal gingival margin
Time frame: 6 months
Mean root coverage(MRC)
(Baseline recession depth - 6 month recession depth/Baseline recession depth)\*100
Time frame: 6 months
Complete root coverage(CRC)
root coverage regarded as complete with gingival margin located at the level of Cemento Enamel Junction
Time frame: 6 months
coverage esthetic score(RCES)
The Aesthetic evaluation was performed according to the root coverage aesthetic score system (RES) Five Variables evaluated which are as follows: 1. Level of Gingival margin (GM) 2. Marginal Tissue Contour (MTC) 3. Soft Tissue Texture (STT) 4. Mucogingival Junction(MJ) alignment 5. Gingival Colour (GC)
Time frame: 6 months
probing pocket depth (PD)
measured as the distance from the gingival margin to the base of gingival sulcus
Time frame: 6 months
clinical attachment level (CAL)
measured as Gingival Recession Depth + Probing Depth
Time frame: 6 months
width of keratinized tissue (KTW)
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measured as the distance from the mucogingival junction to the gingival margin , with the mucogingival junction location determined using a visual method (Schiller's Potassium Iodide Solution).
Time frame: 6 months