Periodontal Surgery With Early vs Delayed Endodontic Treatment in Endo-Perio Lesions Without Communication

NCT03230344 | Unknown DMC

• 1 other identifier: Ruchika perio
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the periodontal parameters in terms of periodontal healing by periodontal surgical therapy with simultaneous or delayed endodontic therapy in management of concurrent endodontic -periodontal lesion without communication

Conditions

Periodontal and Endodontic Lesion

Outcome Measures

Primary Outcomes (1)

• periodontal parameter: CAL

  Clinical attachment level

  7.5 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Periodontal treatment initiated with scaling and root planing along with root canal treatment and followed by open flap debridement after 6 weeks.(Open flap debridement simultaneously with root canal treatment )

Procedure: open flap debridement

Group 2

EXPERIMENTAL

Periodontal treatment initiated with scaling and root planing followed by open flap debridement after 6 weeks. Endodontic treatment will be initiated after 3 months of periodontal surgery.(open flap debridement and delayed root canal treatment )

Procedure: open flap debridement

Interventions

open flap debridement PROCEDURE

open flap debridement simultaneously with root canal treatment

Also known as: root canal treatment

Group 1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of age 18 years and above, systematically healthy with chronic periodontitis having at least one tooth involving endodontic periodontal lesion without apical communication with following radiographic and clinical features:
• Wide base pocket, deep pocket depth
• Non vital tooth (confirmed by heat test, cold test and electronic pulp test)
• Radiographic periapical alveolar bone destruction and marginal bone loss without apical communication .

You may not qualify if:

• :• Systemic illness known to affect the periodontium or outcome of periodontal therapy.
• Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy.
• Patients allergic to medication (local anaesthetic, antibiotics, NSAID).
• Pregnant or lactating mothers.
• Smokers and tobacco chewers.
• Grade 3 mobile teeth.
• Unrestorable tooth.
• Fractured/perforated roots.
• Developing permanent tooth.
• Previously root canal filled.
• History of recent periodontal treatment within 6 months prior to study.
• Teeth with established endodontic periodontal lesions exhibiting \<2mm radioopaque bone between the root apex and the periodontal breakdown and with apical communication found during surgery.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

Study Officials

• RUCHIKA LATHER

  POST GRADUATE INSTITUTE OF DENTAL SCIENCES

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TEWARI

CONTACT

9416514600; drshikhatewari@yahoo.com

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: July 13, 2017
• First Posted: July 26, 2017
• Study Start: December 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: July 26, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1yr 6months
• Access Criteria: PGIDS, Rohtak Haryana

Locations

IN (1)