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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pt receiving SCR treatment | Active Comparator | No disinfectant solution was applied (control group). |
|
| Pt receiving SCR followed by disinfection with NaOCl | Experimental | the cavity was disinfected with 2.5% sodium hypochlorite |
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| Pt receiving SCR followed by disinfection with Chlorhexidine | Experimental | The cavity was disinfected with 2% CHX. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selective caries removal | Procedure | Selective caries removal followed by cavity disinfection with NaOCl & CHX in each test group & no cavity disinfection in control group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shweta Mittal | Contact | 9255596960 | shwetagoelendo@gmail.com | |
| Dr Parichay Singhal | Contact | 9717710642 | parichaysinghal11@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr Sanjay Tewari, MDS | PGIDS Rohtak | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pgids Rohtak | Recruiting | Haryāna | India |
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| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| 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 |
|
| 7 days |