Pulp Disease, Dental
Conditions
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
Detailed description
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.
Interventions
PROCEDURESelective caries removal
Selective caries removal followed by cavity disinfection with NaOCl & CHX in each test group & no cavity disinfection in control group.
PROCEDURESelective caries removal with NaOCl
elective caries removal followed by cavity disinfection with NaOCl
PROCEDURESelective caries removal with CHX
elective caries removal followed by cavity disinfection with CHX
Sponsors
Postgraduate Institute of Dental Sciences Rohtak
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success criteria | 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. |
| Radiographic success criteria | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain assesment | 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. |
Countries
India
Contacts
Primary ContactDr. Shweta Mittal
Backup ContactDr Parichay Singhal
Outcome results
None listed