Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06836882

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

On this page

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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.
Not Eligible

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

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Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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)

Follow-up

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

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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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