A Randomized clinical study to check the inter-appointment pain in patients with infected teeth using two different combination of drugs

Phase 1/2

Completed

• Conditions: Acute apical periodontitis of pulpal origin,

• Registration Number: CTRI/2022/06/043007
• Lead Sponsor: Dr DIKSHIT SOLANKI

Brief Summary

This study is a randomized, double blinded, parallel group clinical study comparing reduction of the inter-appointment pain between double antibiotic paste and modified double antibiotic paste containing valacyclovir for 12 months on 72 patients at department of conservative dentistry and endodontics, km shah dental college and hospital. The primary outcome measure will be inter-appointment pain reduction at 6hrs,12hrs, 24hrs,48hrs,3days and 6days.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-06
• Last Update Posted: 2024-03-04
• Study Completion: 2024-03-22

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Systemically healthy patients between age group of 18-60 years with maxillary or mandibular single rooted infected/necrotic teeth with symptomatic apical periodontitis will be included in the study.
• Symptomatic chronic irreversible pulpitis with symptomatic apical periodontitis with loss of lamina dura will be included.
• Symptomatic teeth showing presence of peri-apical radiolucency suggestive of periapical abscess will be included.
• patients with pre-operative moderate to severe pain will be included.
• A written informed consent will be taken and only those patients ready to sign the consent will be included in the study.

Exclusion Criteria

• Asymptomatic teeth with periapical radiolucencies be it abscess or granuloma, etc will be excluded.
• Medically compromised patients will be excluded.
• Teeth with completely obliterated canals will be excluded.
• Teeth with open apex, root resorption or complex root canal anatomy will be excluded.
• Teeth with vertical root canal fractures, cracks, etc will be excluded.
• Patients with deep periodontal disease or endo-perio lesion with periodontal phase dominant will be excluded.
• Pregnant and lactating women will be excluded.
• Patients using other medications such as analgesics or anti-inflammatory drugs during inter appointment will be excluded.
• Patients allergic to antibiotics and anti-viral drugs will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interappointment pain assessment	6hr,12 hr,24hr,3 days,6days

Secondary Outcome Measures

Name	Time	Method
efficacy of modified double antibiotic paste in pain management	6hr,12 hr,24hr,3 days,6days

Trial Locations

Locations (1)

Km shah dental college; 🇮🇳 Vadodara, GUJARAT, India

Km shah dental college

🇮🇳Vadodara, GUJARAT, India

Dr Dikshit Solanki

Principal investigator

7977557010

dmsolanki170997@gmail.com