Investigating the effects of disinfectants on pain and success in dental procedures
The Effect of Sodium Hypochlorite and Chlorhexidine as Cavity Disinfectants on the Post Operative Pain and Success of Partial Caries Removal in Deep Carious Lesion With Moderate Pulpitis in Permanent Teeth: A Randomized Controlled Trial
This study is testing whether using sodium hypochlorite or chlorhexidine as disinfectants during dental procedures can help reduce pain and improve success for patients with deep cavities compared to using saline.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 159 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Postgraduate Institute of Dental Sciences Rohtak Academic / other |
| Locations | 1 site (Haryāna) |
| Trial ID | NCT06836882 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of sodium hypochlorite and chlorhexidine as cavity disinfectants during partial caries removal in patients with deep carious lesions and moderate pulpitis. The research will compare the clinical and radiographic outcomes of using these disinfectants against saline in mature permanent mandibular molars. Patients will be monitored for post-operative pain levels and treatment success over a 12-month follow-up period. The study includes a detailed assessment of pain reduction at 24-hour intervals for the first week post-procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with restorable mature permanent mandibular molars exhibiting deep caries and moderate pulpitis.
Not a fit: Patients with vertical root fractures, root perforations, or those classified as ASA-3 or ASA-4 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and treatment outcomes for patients undergoing dental procedures for deep carious lesions.
How similar studies have performed: Previous studies have shown varying degrees of success with similar disinfectant approaches in dental treatments, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The patient should be ≥18 years of age. 2. Restorable mature permanent 1st and 2nd Mandibular molars with extremely deep caries (≥2/3 dentine involvement) 3. Tooth should give positive response to pulp sensibility testing. 4. Clinical diagnosis of moderate pulpitis. 5. Radiographic finding of periapical index (PAI) score ≤2. 6. Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit) Exclusion Criteria: Presence of vertical root fracture Presence of root perforations ASA-3 or ASA-4 according to the classification of the American Society of Anesthesiologists) Presence of root resorption Combined endodontic-periodontic lesions. Pregnancy
Where this trial is running
Haryāna
- Pgids Rohtak — Haryāna, India (Recruiting)
Study contacts
- Principal investigator: Dr Sanjay Tewari, MDS — PGIDS Rohtak
- Study coordinator: Dr. Shweta Mittal
- Email: shwetagoelendo@gmail.com
- Phone: 9255596960
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.