Regenerative phenotypic modification therapy: A non-randomized prospective pilot clinical trial (PMT TRIAL)

(ii)     After CTRI approval, selected subjects will be explained about the details of the surgical procedure and a written informed consent will be obtained. All the subjects will undergo Phase I periodontal therapy as per laid out protocols and shall be reviewed after 4 to 6 weeks. They will be subjected to CBCT with low FOV (Field of Volume) restricted to the site of interest at baseline. The parameters observed will include the fwg.

(aa)        Crestal gingival thickness (CGT)

This radiological parameter will be measured as a distance between the facial surface of the gingiva and the labial bone surface at a distance of 2 mm from the edge of the alveolar crest, perpendicular to the osseous surface in CBCT. The measurement will be made at three points; mesial, midfacial & distal sites.

(ab)     Thickness of labial plate of the alveolar crest (TLPAC)

This radiological parameter TLPAC will be measured in a plane perpendicular to the tooth axis, mid-buccal from the inner to the labial surface of the bone of the alveolar crest. The TLPAC was measured at 3 points: 2 mm, 4 mm, and 8 mm from the margin of the labial plate of the alveolar crest in the apical direction in CBCT. Each level measurements will be made at three points; mesial, midfacial & distal sites.

(ac)     Width of keratinized tissue (WKT)

It will be measured clinically using a periodontal probe calibrated      every 1 mm (UNC 15, Hu Friedy, USA).

(ad)     Recession height (RH)

The presence or absence of MTR will be noted as a binary variable. When present, it will be measured clinically from cemento-enamel junction as landmark using a periodontal probe calibrated every 1 mm (UNC 15, Hu Friedy, USA).

(iii)    All the four study parameters will be measured at baseline and 12 months and 24 months post-operatively by single operator / observer (PW) after calibrating for intra-operator reliability. The CBCT technique will be calibrated and standardized by the operator for intra-operator reliability. All the subjects will be included in standard supportive periodontal treatment regimen at interval of 3 months post-operatively.

(iv)   The surgical phase will include lateral access tunnel technique under local anesthesia using bilateral access one tooth adjacent to sites of thin periodontal phenotype. A flexible bone substitute made of Beta Tricalcium phosphate with 2 mm thickness will be soaked in normal saline for 30 secs and 0.3mL of EMD (Enamel Matrix Derivative) will be coated on both surfaces of the flexible osseous substitute. The EMD treated osseous scaffold will be carefully introduced into the tunnel and molded over the labial bone surface, 2mm below the gingival margin. The access tunnel will be secured 6/0 Monofilament Polyglycolic sutures. The patients will be subjected to standard post-operative care and supportive periodontal treatment for once in 3 months and followed up to 24 months.

(v)           Statistical Analysis

The data collected by the principal worker at ADC (R&R) will be compiled and subjected to statistical analysis. The statistical analysis will be done by relevant statistical methods using appropriate software.