Health TrialsbyHealthPanel

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

ConditionPulp Disease, Dental
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPostgraduate Institute of Dental Sciences Rohtak

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Selective caries removal

    Procedure/Surgery

    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/Surgery

    elective caries removal followed by cavity disinfection with NaOCl

  • Selective caries removal with CHX

    Procedure/Surgery

    elective caries removal followed by cavity disinfection with CHX

Treatment groups

159 Participants
are divided into 3 treatment groups
Group A: Pt receiving SCR treatmentActive comparator 1 intervention
Group B: Pt receiving SCR followed by disinfection with NaOClExperimental treatment 2 interventions
Group C: Pt receiving SCR followed by disinfection with ChlorhexidineExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12mnths

Secondary outcomes

1

Pain assesment

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.

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Postgraduate Institute of Dental Sciences Rohtak

Lead sponsor

Source ClinicalTrials.gov
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