Effect of Cavity Disinfectants on Post Operative Pain & Success of Partial Caries Removal

NCT ID: NCT06836882

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-23

Study Completion Date

2025-12-23

Brief Summary

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To investigate 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

Detailed Description

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Study Design: Intervention Research Question : To investigate whether the use of 2% chlorhexidine and 5.25% sodium hypochlorite can improve the clinical and radiographic outcome after partial caries removal in deep carious lesion P (Population) - Mature Permanent Mandibular molars with deep carious lesion involving inner two third of dentine I (Intervention) - - Partial caries removal using 2% chlorhexidine/5.25% sodium hypochlorite as cavity disinfectant..

C (Comparison) - Partial caries removal using saline as cavity disinfectant. O (Outcome) - Assessment of clinical and radiographic success at 12 months follow up.

-To assess incidence and reduction in pain post operatively at every 24 hours till 1 week.

Conditions

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Pulp Disease, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Pt receiving SCR treatment

No disinfectant solution was applied (control group).

Group Type ACTIVE_COMPARATOR

Selective caries removal

Intervention Type PROCEDURE

Selective caries removal followed by cavity disinfection with NaOCl \& CHX in each test group \& no cavity disinfection in control group.

Pt receiving SCR followed by disinfection with NaOCl

the cavity was disinfected with 2.5% sodium hypochlorite

Group Type EXPERIMENTAL

Selective caries removal

Intervention Type PROCEDURE

Selective caries removal followed by cavity disinfection with NaOCl \& CHX in each test group \& no cavity disinfection in control group.

Selective caries removal with NaOCl

Intervention Type PROCEDURE

elective caries removal followed by cavity disinfection with NaOCl

Pt receiving SCR followed by disinfection with Chlorhexidine

The cavity was disinfected with 2% CHX.

Group Type EXPERIMENTAL

Selective caries removal

Intervention Type PROCEDURE

Selective caries removal followed by cavity disinfection with NaOCl \& CHX in each test group \& no cavity disinfection in control group.

Selective caries removal with CHX

Intervention Type PROCEDURE

elective caries removal followed by cavity disinfection with CHX

Interventions

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Selective caries removal

Selective caries removal followed by cavity disinfection with NaOCl \& CHX in each test group \& no cavity disinfection in control group.

Intervention Type PROCEDURE

Selective caries removal with NaOCl

elective caries removal followed by cavity disinfection with NaOCl

Intervention Type PROCEDURE

Selective caries removal with CHX

elective caries removal followed by cavity disinfection with CHX

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Sanjay Tewari, MDS

Role: PRINCIPAL_INVESTIGATOR

PGIDS Rohtak

Locations

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Pgids Rohtak

Haryāna, , India

Site Status RECRUITING

Countries

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India

Central Contacts

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Dr. Shweta Mittal

Role: CONTACT

9255596960

Dr Parichay Singhal

Role: CONTACT

9717710642

Facility Contacts

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PARICHAY SINGHAL, PG STUDENT

Role: primary

9717710642

SHWETA MITTAL, MDS

Role: backup

9255596960

Other Identifiers

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shweta mittal

Identifier Type: -

Identifier Source: org_study_id

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