Estimation of MMP-8 Levels in GCF and Serum and Its Correlation With Wound Healing and Clinical Outcomes After Coronally Advanced Flap and Subepithelial Connective Tissue Graft for Root Coverage in Recession Defects: A CLINICO-BIOCHEMICAL STUDY

NCT02863744 | Suspended Phase 4

• 1 other identifier: 02-D012-54506
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

Assessment of wound healing progression after surgery is important. Currently blunt surrogate markers such as probing is used. Limitation of these markers is that it represents the history of healing and not the ongoing activity. As hallmark of healing is collagen remodeling, it is of interest to study the cytokine profile that relates to wound healing. Such knowledge may potentially lead to new diagnostic strategies to study wound healing in a better way reflecting the healing phenotype. Understanding wound healing at molecular level provides an in depth basis to develop treatment strategies that can prevent delayed healing.2 As recommended by Consensus Report of 10th European workshop on periodontology that, there is a need for more studies at cellular level to identify cytokine, chemokine, and intracellular signaling networks for better regenerative approaches10, the present clinical trial was designed. On account of a considerable lacunae in this area of periodontal research, this study is planned to assess the MMP-8 levels during the post-op healing following CAF+SCTG surgery for recession coverage and to better identify the mechanism involved in wound healing. This information can be used to prevent the normal surgical wound from altered healing experience.

Conditions

Wound Healing

Keywords

mmp-8; early stages of wound healing; wound healing marker

Outcome Measures

Primary Outcomes (4)

• MMP-8 levels in GCF and serum and correlation with initial wound healing with recording Wound Healing indices (WHI) assessed on 4th day

  subsequent post surgical follow up after CAF+SCTG procedure (4th day post surgery)

• MMP-8 levels in GCF and serum and correlation with initial wound healing with recording Wound Healing indices (WHI) assessed on 7th day

  subsequent post surgical follow up after CAF+SCTG procedure (7th day post surgery)

• Quantitative analysis of GCF samples for mmp-8 in ng/site and its correlation with clinical outcome after 6 months

  6 month post surgical follow up.

• Correlation of GCF and serum MMP-8 values

  6 month post surgical follow up

Secondary Outcomes (8)

• Gingival Recession depth (GRD)

  6 months

• Gingival Recession Width (GRW)

  6 months

• Apico coronal width of keratinised tissue (KTW)

  6 months

• Clinical Attachment Level (CAL)

  6 months

• Probing Depth (PD)

  6 months

Study Arms (1)

CAF+SCTG

EXPERIMENTAL

Procedure: coronally advanced flap with subepithelial connective tissue graft

Interventions

coronally advanced flap with subepithelial connective tissue graft PROCEDURE

* Under local anesthesia 2% lignocaine hydrochloride using a No. 15 BP (Bard Parker) blade full thickness flap will be elevated till the MGJ (mucogingival junction) using a small periosteal elevator and a partial-thickness flap will be raised beyond the mucogingival junction to allow a passive coronal displacement of the flap completely covering the CEJ without tension. * The donor site consisting of 2 mm thick palatal connective tissue graft will be harvested from the premolar to the first molar area using the 'trap door' technique.14 The connective tissue graft will be secured in position with 4-0 absorbable sutures in recipient sites. The flaps will be stabilized with sling suture in a coronal position, followed by interrupted suture on releasing incisions in an apico-coronal direction using 4-0 absorbable sutures.

CAF+SCTG

Eligibility Criteria

• Age: 25 Years - 57 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Miller's Class I and II recession in maxillary anteriors.
• Patients with thick gingival biotypes \>0.8mm.
• Width of keratinised gingiva \>1mm
• Patients willing to participate in study.
• Age group of 25-57 years.
• Patients with history of compliance to oral hygiene instructions and a full mouth plaque score of \<20%.(O Leary 1972)
• American society of Anesthesiologists Physical status I or II.
• No contra-indications for periodontal surgery.
• Patients with esthetic concerns.

You may not qualify if:

• Patients with a medical history likely to influence the inflammatory response (atherosclerosis, rheumatoid arthritis, oral cysts, inflammatory bowel disease, bronchiectasis, asthma ,hypertension and diabetes).
• Recession defects associated with caries/demineralization, restorations, and deep abrasions.
• No occlusal interferences
• Teeth with evidence of pulpal pathology.
• Patients who had received antibiotic therapy within the last 3 months.
• Pregnant and lactating woman.
• Patients who have undergone any type of regenerative periodontal therapy six months prior to the initial examination.
• Patients with history of smoking.
• Teeth with hopeless prognosis.

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 11, 2016
• Study Start: December 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 11, 2016

Record last verified: 2016-07