Influence of Gingival Biotype on the Outcome of Open Flap Debridement

NCT03882138 | Completed DMC

• 1 other identifier: perio bhumika
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The influence of periodontal thickness has been documented in outcome of various periodontal interventions like non surgical periodontal therapy, mucogingival therapy, guided tissue regeneration (GTR), crown lengthening and implant dentistry. There is lack of study showing the influence of gingival biotype on outcome of surgical procedure. The present study is therefore undertaken to evaluate the influence of gingival biotype on the outcome of open flap debridement for treatment of chronic periodontitis.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• clinical attachment level

  clinical attachment level is measured from cementoenamel junction to base of pocket

  6 months

Study Arms (2)

thin biotype

ACTIVE COMPARATOR

Modified Widman flap surgery followed by meticulous debridement, root planning and thorough irrigation with normal sterile saline solution

Procedure: open flap debridement

thick biotype

ACTIVE COMPARATOR

Modified Widman flap surgery followed by meticulous debridement, root planning and thorough irrigation with normal sterile saline solution

Procedure: open flap debridement

Interventions

open flap debridement PROCEDURE

Modified Widman flap surgery followed by meticulous debridement, root planning and thorough irrigation with normal sterile saline solution

thick biotype; thin biotype

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy patients with moderate to severe chronic periodontitis
• Age 25-55 years
• Clinical attachment loss(CAL) ≥3 mm
• Probing pocket depth (PPD) ≥5 mm
• Possessing ≥20 natural teeth.

You may not qualify if:

• Patients with vertical bone loss
• Current or former smokers or use of tobacco in any form
• Pregnant women, lactating mothers and women taking oral contraceptives
• Patient who had undergone periodontal treatment within 6 months prior to the study
• Patient on anti-inflammatory drugs or antibiotics or history of treatment with medication known to influence periodontal status or healing such as statins, glucocorticoids, phenytoin, calcium channel blockers, immunosuppressants, bisphosphonates or any other host modulatory drug within six months of commencement of study
• Patient with average plaque index ≥1.5 after phase 1 therapy
• Miller Grade II /Grade III tooth mobility after SRP
• Periapical infection in any tooth of the surgical treatment segment.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 20, 2019
• Study Start: December 1, 2017
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)