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NCT Number: NCT06836882

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

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

Treatment and study plan

Selective caries removal

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

Procedure

elective caries removal followed by cavity disinfection with NaOCl

Selective caries removal with CHX

Procedure

elective caries removal followed by cavity disinfection with CHX

Primary outcomes

  1. Clinical success criteria

    Time frame: 12 months

    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.

  2. Radiographic success criteria

    Time frame: 12mnths

    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.

Secondary outcomes

  1. Pain assesment

    Time frame: 7 days

    Patients will be informed that they may experience pain in the days after treatment and will be instructed to record their pain at 24 h, 2, 3, 4, 5, 6 and 7 days after the treatment, to be submitted after 1 week.

    They will be instructed to use analgesics (Ibuprofen 400 mg every 6-8 h), if needed for pain relief. They will be requested to note down the details of analgesic intake on the pain form regarding the number of doses required, timing of the dose and whether it provided adequate pain relief or not (yes/no) Visual analogue scale (VAS) from 0 to 100 will be used to record preoperative and post -operative pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Parichay Singhal

CONTACT

[email protected]

9717710642

Dr. Shweta Mittal

CONTACT

[email protected]

9255596960

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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