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Effect of Sodium Hypochlorite and Chlorhexidine on Post Operative Pain and Success of Partial Caries Removal in Deep Carious Lesions with Moderate Pulpitis in Permanent Teeth: A Randomized Controlled Trial
Led by Postgraduate Institute of Dental Sciences Rohtak · Updated on 2025-02-20
159
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the effects of sodium hypochlorite and chlorhexidine as disinfectants on post-operative pain and the success of partial caries removal in mature permanent mandibular molars with deep carious lesions and moderate pulpitis. The study aims to compare the clinical and radiographic outcomes after partial caries removal using these disinfectants versus saline. The research focuses on improving treatment results for deep dental cavities while monitoring pain reduction after the procedure. Participants will undergo partial caries removal followed by cavity disinfection with either 2% chlorhexidine, 5.25% sodium hypochlorite, or saline (control group). The study includes randomized allocation into one of three groups: no disinfectant, sodium hypochlorite disinfection, or chlorhexidine disinfection. Treatment success will be assessed after 12 months, while post-operative pain will be monitored daily for one week. During the study, participants will receive clinical and radiographic evaluations at 12 months to measure the success of the treatment. Pain assessments will be conducted every 24 hours for seven days following the procedure. The research team will track both clinical and radiographic success criteria and monitor pain levels to evaluate the effectiveness of the disinfectants used. The total follow-up period for the primary outcomes is 12 months.
CONDITIONS
Brief Title
Effect of Cavity Disinfectants on Post Operative Pain & Success of Partial Caries Removal
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient should be 18 years of age or older.
- Restorable mature permanent 1st and 2nd mandibular molars with extremely deep caries (involving two-thirds or more of the dentine).
- Tooth should give a positive response to pulp sensibility testing.
- Clinical diagnosis of moderate pulpitis.
- Radiographic finding with periapical index (PAI) score of 2 or less.
- Healthy periodontium with probing pocket depth of 3 mm or less and normal tooth mobility.
You will not qualify if you...
- Presence of vertical root fracture.
- Presence of root perforations.
- American Society of Anesthesiologists (ASA) classification of 3 or 4.
- Presence of root resorption.
- Combined endodontic-periodontic lesions.
- Pregnancy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single treatment visit
Participants receive selective caries removal followed by cavity disinfection with either 2.5% sodium hypochlorite, 2% chlorhexidine, or no disinfectant (control group).
1 visit (in-person)
Duration - 12 months
Participants are monitored for post-operative pain every 24 hours for 7 days and assessed for clinical and radiographic success at 12 months.
Daily pain assessments for 7 days and 1 visit at 12 months
Trial Site Locations
Total: 1 location
1
Pgids Rohtak
Haryāna, India
Actively Recruiting
Research Team
D
Dr. Shweta Mittal
D
Dr Parichay Singhal
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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