NCT06836882

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

1.6 years

First QC Date

January 9, 2025

Last Update Submit

February 15, 2025

Conditions

Pulp Disease, Dental

Outcome Measures

Primary Outcomes (2)

  • Clinical success criteria

    No history of spontaneous pain or discomfort except for the initial days after treatment. No tenderness to palpation or percussion and the tooth is functional. Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract.

    12 months

  • Radiographic success criteria

    No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 according to OrstavicKet al.

    12mnths

Secondary Outcomes (1)

  • Pain assesment

    7 days

Study Arms (3)

Pt receiving SCR treatment

ACTIVE COMPARATOR

No disinfectant solution was applied (control group).

Procedure: Selective caries removal

Pt receiving SCR followed by disinfection with NaOCl

EXPERIMENTAL

the cavity was disinfected with 2.5% sodium hypochlorite

Procedure: Selective caries removalProcedure: Selective caries removal with NaOCl

Pt receiving SCR followed by disinfection with Chlorhexidine

EXPERIMENTAL

The cavity was disinfected with 2% CHX.

Procedure: Selective caries removalProcedure: Selective caries removal with CHX

Interventions

Selective caries removalPROCEDURE

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 ChlorhexidinePt receiving SCR followed by disinfection with NaOClPt receiving SCR treatment
Selective caries removal with NaOClPROCEDURE

elective caries removal followed by cavity disinfection with NaOCl

Pt receiving SCR followed by disinfection with NaOCl
Selective caries removal with CHXPROCEDURE

elective caries removal followed by cavity disinfection with CHX

Pt receiving SCR followed by disinfection with Chlorhexidine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient should be ≥18 years of age.
  • Restorable mature permanent 1st and 2nd Mandibular molars with extremely deep caries (≥2/3 dentine involvement)
  • Tooth should give positive response to pulp sensibility testing.
  • Clinical diagnosis of moderate pulpitis.
  • Radiographic finding of periapical index (PAI) score ≤2.
  • Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pgids Rohtak

Haryāna, India

RECRUITING

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Dr Sanjay Tewari, MDS

    PGIDS Rohtak

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Shweta Mittal

CONTACT

9255596960shwetagoelendo@gmail.com

Dr Parichay Singhal

CONTACT

9717710642parichaysinghal11@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2025

First Posted

February 20, 2025

Study Start

May 23, 2024

Primary Completion

December 23, 2025

Study Completion

December 23, 2025

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)