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Post-treatment Pain evaluation Using Two Different intracanal medicaments In Pulpally Necrosed Teeth with periapical lesions: A Randomized clinical Study

Comparative Evaluation of Postoperative Pain Following the Placement of Calcium Hydroxide with propylene glycol and calcium hydroxide with Chlorhexidine as Intracanal Medicament in Necrotic Teeth with Periapical Lesions: A Randomized Controlled Trial. - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088557
Enrollment
102
Registered
2025-06-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K041- Necrosis of pulp

Interventions

Intervention1: calcium hydroxide with chlorhexidine: placement of calcium hydroxide-0.2%chlorhexidine as intracanal medicaments for necrotic teeth with periapical lesions case Control Intervention1:

Sponsors

MGM Dental College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants who accept the study goals and requirements and are willing to participate in the study All participants are in good health based on their written health histories and oral interviews Participants range in age from 18 to 50 year old with both male and female participants Participants with mild and moderate pain involving one tooth All non vital molar teeth with apical periodontitis Participants with PAI index score of 2 and 3 lesion will be less than 5mm in diameter as determined in intraoral periapical radiograph Using the canal curvature less than 20 degree as per schneider method Thermal and electric pulp tests yielded a delayed or negative result Only teeth with favourable conditions for rubber dam application are considered Teeth with fully developed apex Teeth with healthy periodontium with periodontal probing depth less than or equal to 3 mm permanent teeth Intact teeth with no cracks or defects Teeth with patent canals

Exclusion criteria

Exclusion criteria: 1. Participant who have taken antibiotics in past 1 month. 2. Participant who have taken analgesic within past 48 hrs. 3. Patients presenting with severe pain (75 to 100 mm) 4. Participants who will not accept the study freely. 5. Participants who do not provide authorization for participation. 6. Participants below 18 years and above 50 years of age. 7. Pregnant women and nursing mothers. 8. Participants with vital teeth 9. Participants with acute or chronic dentoalveolar abscess or cellulitis. 10. Participants whose tooth has been accessed previously or endodontically treated. 11. Participants whose teeth after access was found to be bleeding. 12. Participants who have taken medications which, in the opinion of the investigator, could interfere with the conduct of the study (eg. corticosteroids, antibiotics and analgesics in the past month). 13. Participants with known systemic disorders or immunocompromised conditions (e.g. diabetes, HIV positive ) 14. Participants who have a current or recent history of alcohol or other substance abuse. 15. Participants with PAI index score 1 16. single rooted canals, calcified canals, open apex, root resorption, presence of root caries and multirooted teeth. 17. Teeth with aggressive periodontitis and grade III mobility, periodontal probing depth greater than 3mm. 18. Severe labially or lingually malposition teeth in which obtaining straight-line access will be difficult. 19. Teeth are indicated for intentional endodontic therapy for prosthetic reasons. 20. PAI index 4 and 5 with well defined radiolucency as determined in intraoral periapical radiograph. 21. Participants with an intraoral and extraoral sinus tract. 22. Teeth with open apex 23. Teeth with internal and external root resorption 24. Teeth with presence of root caries 25. Teeth with canal aberrations. 26. Teeth with calcified canals 27. Primary teeth

Design outcomes

Primary

MeasureTime frame
Assessment of postoperative pain using validated pain scales like VAS during the follow-up period.Timepoint: 6hrs, 24hrs, 7 days and after 14 days for pain evaluation

Secondary

MeasureTime frame
Radiographic evaluation of the size and resolution of periapical lesions to determine the effectiveness of the medicaments in promoting healing over the one-year follow-up period. Timepoint: 1 year follow up period

Countries

India

Contacts

Public ContactDR ANURADHA PATIL

MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE

margsuman@gmail.com9869433642

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026