A Study on Pain and Healing after Root Canal treatment in children using different concentration of cleaning solution

Phase 3

Active, not recruiting

Conditions: Other specified personal risk factors, not elsewhere classified,
Healthy Patients requiring pulpectomy procedures on lower teeth due to dental caries and pain

Registration Number: CTRI/2023/11/059520

Lead Sponsor: Divya Mukundan

Brief Summary: In this split-mouth, double-blinded randomized control trial, we aimed to compare the efficacy of two different concentrations of sodium hypochlorite, 1% and 3%, as irrigants during pulpectomy procedures. The study will assess post-operative pain, radiographic success, and clinical outcomes in patients with similar pulp pathologies. Both patients and the observer were blinded to the sodium hypochlorite concentration used on each side of the mouth to minimize bias. Post-operative pain was evaluated using standardized pain scales; radiographic success was determined through pre-operative and post-operative radiographs taken at an interval of 3 months, 6 months, 9 months, and 12 months; and clinical success was assessed through clinical examinations and patient-reported outcomes at an interval of 3 months, 6 months, 9 months, and 12 months. The results of this trial will provide valuable insights into the impact of sodium hypochlorite concentration on the overall success of pulpectomy, aiding pedodontists in making informed decisions regarding the choice of irrigation solution for improved patient outcomes and quality of care.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 28

Inclusion Criteria

Healthy patients, Teeth with apical periodontitis after clinical and radiographic confirmation, Presence of 2/3rd of root length and mandibular primary molars.

Exclusion Criteria

Any known history of allergy to any medications; Medically compromised children; tooth with complications such as perforations, fractures and root calcifications, children not under any analgesics or anti-inflammatory drugs for the past 1 week.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post operative pain	6 hours, 12 hours, 24 hours

Secondary Outcome Measures

Name	Time	Method
Radiographic success	clinical success

Trial Locations

Locations (1): Saveetha Dental college and Hospitals
🇮🇳
Chennai, TAMIL NADU, India
Saveetha Dental college and Hospitals
🇮🇳Chennai, TAMIL NADU, India
Dr Divya Mukundan
Principal investigator
8220492973
divyamukundan1694@gmail.com