Effect of Propolis paste as compared to Calcium hydroxide on post-root canal treatment pain when inserted in root canals of infected teeth

Phase 3

Completed

• Conditions: Condition as of 30/10/2018: Necrosis of pulpPrevious condition:Domain in healthcare is dentistry and the condition we will be studying is Necrotic teeth with symptomatic apical periodontitis; Oral Health; Necrotic teeth with symptomatic apical periodontitis

• Registration Number: ISRCTN66816132
• Lead Sponsor: Dow University of Health Sciences

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/31936519 results (added 07/04/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33511602/ effect of variables such as age, gender, and tooth type on postoperative endodontic pain (added 18/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-24
• Study Completion: 2018-10-15
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Participant inclusion criteria as of 30/10/2018:
1. Aged 20-40 years
2. Both male and female both
3. Single rooted Necrotic teeth with symptomatic or asymptomatic periapical periodontitis having visible periapical widening or radiolucency without bone expansion (PAI index 2, 3 and 4)
4. Teeth with favorable root morphology
5. Teeth with closed apex

Previous participant inclusion criteria:
1. Aged 20-40 years
2. Both male and female both
3. Single rooted Necrotic teeth with symptomatic periapical periodontitis having visible periapical widening or radiolucency without bone expansion (PAI index 3 and 4)
4. Teeth with favorable root morphology
5. Teeth with closed apex

Exclusion Criteria

Participant exclusion criteria as of 30/10/2018:
1. Teeth with PAI index 1 and 5
2. Patients who are on antibiotics
3. Patient with recent trauma to the jaw
4. Teeth with open apex
5. Multi-rooted teeth
6. Vital teeth
7. Non-restorable teeth
8. Unfavorable root morphology (severely curved, dilacerated, severely sclerosed or obliterated)
9. Teeth associated with soft tissue abscess or swelling
10. Teeth with external and internal root resorption
11. Re-treatment cases
12. Periodontally compromised teeth (like mobile teeth and teeth with excessive bone loss)
13. Teeth requiring endodontic surgery
14. Teeth requiring non-surgical endodontic treatment of multiple teeth in the same or opposing quadrant
15. Medically compromised patients (ASA-III and above), patients with special communication needs or who doesn’t understand urdu or English language
16. Patients allergic to bee pollen or honey products

Previous participant exclusion criteria:
1. Teeth with PAI index 1, 4 and 5
2. Patients who are on antibiotics
3. Patient with recent trauma to the jaw
4. Teeth with open apex
5. Multi-rooted teeth
6. Vital teeth
7. Non-restorable teeth
8. Unfavorable root morphology (severely curved, dilacerated, severely sclerosed or obliterated)
9. Teeth associated with soft tissue abscess or swelling
10. Teeth with external and internal root resorption
11. Re-treatment cases
12. Periodontally compromised teeth (like mobile teeth and teeth with excessive bone loss)
13. Teeth requiring endodontic surgery
14. Teeth requiring non-surgical endodontic treatment of multiple teeth in the same or opposing quadrant
15. Medically compromised patients (ASA-III and above), patients with special communication needs or who doesn’t understand urdu or English language
16. Patients allergic to bee pollen or honey products

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measure as of 30/10/2018:<br>1. Pain intensity measure: Visual Analogue Pain Scale. Difference of the pain scores between the two groups at different time intervals.<br><br>Previous primary outcome measure:<br>1. Pain score is recorded by the patient using the Visual Analogue Scale (VAS scale) at four, 12, 24, 48 and 72 hours<br>2. Number of patients reaching the full followup period without taking oral analgesic is measured using the Visual Analogue Scale (statistically analysed during processing (after VAS scales are collected from all of the patients) to know how many patients reached the full follow up period of 72 hours without taking any oral analgesic) at 72 hours