Effect of Sodium Hypochlorite Concentration on Success of Non-surgical Root Canal Treatment

NCT03288467 | Completed DMC

• 1 other identifier: Neha Verma
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

.There is no general agreement regarding the optimal concentration of sodium hypochlorite to be used in endodontic treatment.Therefore, this study aims to evaluate the effect of sodium hypochlorite concentration on the success of primary root canal treatment. The study population comprised of patients requiring primary root canal treatment following the diagnosis of pulpal necrosis with chronic apical periodontitis in mature mandibular first and second molars.Patients were randomly allocated in either High concentration or Low concentration group.

Conditions

Apical Periodontitis

Outcome Measures

Primary Outcomes (2)

• Radiographic success

  Treatment outcome was judged on the basis of radiographic findings recorded at the follow up visit and comparison of the radiographs obtained at post obturation and the follow-up visit.Change in Periapical Index (PAI) scores observed at 12-months was noted and scoring of each tooth was done according to the PAI scores and score less than 3 were considered as success.

  Every 3 months till 12 months

• Clinical success

  Absence of pain and tenderness to palpation/ percussion, absence of sinus or any associated soft tissue swelling, tooth mobility, and no deterioration in periodontal probing depth as compared with baseline measurements comprised the criteria for clinical success.

  Till 12 months

Secondary Outcomes (1)

• Pain intensity

  Pain intensity recorded at different intervals (preoperatively, after 6 hours, 12 hours, 1day, 2 days, 3 days, 4days, 5 days, 6 days and 7 days).

Study Arms (2)

Root canal treatment with 5% NaOCl

ACTIVE COMPARATOR

Root canal treatment with 5% NaOCl: 5 ml of 5% sodium hypochlorite was used during root canal treatment after each instrument change.After root canal instrumentation, canals irrigated with 5ml of 17% EDTA solution for 1 minute followed by final wash with 5ml of 5% sodium hypochlorite.

Procedure: Root canal treatment with 5% NaOCl

Root canal treatment with 1% NaOCl

ACTIVE COMPARATOR

5 ml of 1% soium hypochlorite was used during root canal treatment after each instrument change.After root canal instrumentation, canals irrigated with 5ml of 17% EDTA solution for 1 minute followed by final wash with 5ml of 1% sodium hypochlorite.

Procedure: Root canal treatment with 1% NaOCl

Interventions

Root canal treatment with 5% NaOCl PROCEDURE

Also known as: Endodontic treatment

Root canal treatment with 5% NaOCl

Root canal treatment with 1% NaOCl PROCEDURE

Also known as: Endodontic treatment

Root canal treatment with 1% NaOCl

Eligibility Criteria

• Age: 18 Years - 47 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient willingness to participate in the study
• Mature permanent mandibular first and second molars requiring primary root canal treatment
• Diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber
• Radiographic evidence of periapical radiolucency (minimum size ≥ 2.0 × 2.0 mm)
• Patient's age more than 18 years

You may not qualify if:

• Positive history of antibiotic use within past one month of the treatment.
• Positive history of analgesic use within the past 3 days.
• Patients who are pregnant, diabetic, immunocompromised, had serious medical illness or required antibiotic premedication
• Patients with pockets ≥4mm or having marginal or furcal bone loss due to periodontitis
• Teeth that are not suitable for rubber dam isolation
• Previously accessed teeth and/or with procedural errors
• Unrestorable tooth, fractured/ perforated roots, inflammatory root resorption

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Endodontics

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Dentistry

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: September 11, 2017
• First Posted: September 20, 2017
• Study Start: November 6, 2016
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: May 23, 2018

Record last verified: 2017-09