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

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

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 Overview

• Status: Recruiting
• Conditions: Pulp Disease, Dental
• Intervention / Treatment: Procedure: Selective caries removal; Procedure: Selective caries removal with NaOCl; Procedure: Selective caries removal with CHX

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.

• Study Type: Interventional
• Enrollment (Estimated): 159
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Shweta Mittal; Phone Number: 9255596960; Email: shwetagoelendo@gmail.com
• Study Contact Backup: Name: Dr Parichay Singhal; Phone Number: 9717710642; Email: parichaysinghal11@gmail.com

Study Locations

• India
  • Haryana, India
    • Recruiting
    • PGIDS Rohtak
    • Contact: PARICHAY SINGHAL, PG STUDENT; Phone Number: 9717710642; Email: parichaysinghal11@gmail.com
    • Contact: SHWETA MITTAL, MDS; Phone Number: 9255596960

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pt receiving SCR treatment; No disinfectant solution was applied (control group).	Procedure: Selective caries removal; Selective caries removal followed by cavity disinfection with NaOCl & CHX in each test group & no cavity disinfection in control group.
Experimental: Pt receiving SCR followed by disinfection with NaOCl; the cavity was disinfected with 2.5% sodium hypochlorite	Procedure: Selective caries removal; Selective caries removal followed by cavity disinfection with NaOCl & CHX in each test group & no cavity disinfection in control group.; Procedure: Selective caries removal with NaOCl; elective caries removal followed by cavity disinfection with NaOCl
Experimental: Pt receiving SCR followed by disinfection with Chlorhexidine; The cavity was disinfected with 2% CHX.	Procedure: Selective caries removal; Selective caries removal followed by cavity disinfection with NaOCl & CHX in each test group & no cavity disinfection in control group.; Procedure: Selective caries removal with CHX; elective caries removal followed by cavity disinfection with CHX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	7 days

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: Dr Sanjay Tewari, MDS, PGIDS Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2024
• Primary Completion (Estimated): December 23, 2025
• Study Completion (Estimated): December 23, 2025

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: February 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 15, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Tooth Diseases; Pain, Postoperative; Dental Pulp Diseases; Stomatognathic Diseases
• Other Study ID Numbers: shweta mittal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No