Irrigants on Outcome of Non Surgical Endodontic Retreatment

NCT03719404 | Completed DMC

• 1 other identifier: Kaarunya
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

Brief Summary

Till date, no study has systematically evaluated the role of a single variable on success of endodontic retreatment. While the evaluation of a single factor as the primary objective in a study is a difficult task, it unarguably provides more valuable information regarding the influence of that variable on outcome. The clinical studies comparing the use of Sodium hypochlorite (NaOCl) and Chlorhexidine digluconate (CHX) in retreatment cases have evaluated only the antibacterial effectiveness and there is no clinical study comparing their effect on the clinical outcome in retreatment cases. And also, no study has compared the use of irrigant as single variable in the primary objective on success of retreatment cases. The conclusions drawn from such "surrogate measures" must be interpreted and applied in clinical settings with caution. Since there is no standardised irrigation treatment protocol for secondary root canal treatment, the present study is being conducted to evaluate the effect of 5% NaOCl with 17% Ethylenediaminetetraacetic acid (EDTA) and 2% CHX with 10% citric acid (CA) on outcome, when used as irrigants during the chemomechanical preparation in retreatment cases.

Conditions

Root Canal Infection

Keywords

Retreatment; Irrigants; chlorhexidine

Outcome Measures

Primary Outcomes (1)

• Radiographic success

  Follow up will be done every 3 months till 12 months. Scoring of each tooth will be done according to the following five point scale (PAI). 1- normal periapical structures 2-Small changes in bone structure 3-Changes in bone structure with some mineral loss 4-Periodontitis with well-defined radiolucent area 5-Severe periodontitis with exacerbating features Instructions for scoring using PAI: * All teeth must be given a score * When in doubt assign higher score * For multirooted teeth, use the highest of the scores given to the individual roots. Success was calculated as a dichotomous variable with teeth showing a PAI score of ≤ 2 considered as healed, while those showing a score of ≥3 considered as nonhealed.

  Baseline to one year

Study Arms (2)

sodium hypochlorite group

EXPERIMENTAL

sodium hypochlorite and EDTA are used in endodontic retreatment cases

Procedure: sodium hypochlorite

chlorhexidine group

EXPERIMENTAL

chlorhexidine and citric acid are used in endodontic retreatment cases

Procedure: chlorhexidine

Interventions

sodium hypochlorite PROCEDURE

sodium hypochlorite is used as primary irrigant and edta is used as secondary irrigant in endodontic retreatment cases

sodium hypochlorite group

chlorhexidine PROCEDURE

Chlorhexidine is used as primary irrigant and citric acid is used as secondary irrigant in endodontic retreatment cases

chlorhexidine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously root filled Permanent teeth with post-treatment apical periodontitis requiring nonsurgical root canal retreatment with clinical symptoms like pain on palpation and discomfort to percussion
• Radiographic evidence of periapical radiolucency (minimum size ≥ 2.0 × 2.0 mm)
• previous initial endodontic treatment was done atleast 4 years before.
• Patient's age more than 18 years.
• Patient willingness to participate in the study

You may not qualify if:

• periodontal deep pockets more than 4mm, previous procedural errors, not suitable for rubber dam isolation, vertical root fractures, intraradicular post, marginal or furcal bone loss due to periodontitis, nonrestorable teeth and patients with diabetes, pregnancy, antibiotic medication within last three months, any systemic or immunocompromising conditions.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

MeSH Terms

Interventions

Sodium Hypochlorite; Chlorhexidine

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 25, 2018
• Study Start: October 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share