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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04580862
Other study ID # pop rct
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date June 2021

Study information

Verified date October 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the incidence of post-operative pain after single-visit versus two-visit non-surgical endodontic retreatment.


Description:

Post treatment failure could be treated by two options including orthograde retreatment and apical surgery . In a previous study, orthograde retreatments presented a success rate of 81 % classified as healed and 93 % as no symptoms and fully functional. In a systematic review, it has also been concluded that endodontic surgery offers more favorable initial success but orthograde retreatment yields to a better long-term outcome . Although early results of single-visit treatments are contradictory ; Completing the treatment in a single appointment reduces the treatment time and cost, decreases micro leakage risk and avoids recontamination of root canals between appointments in multiple-visit treatments . Again, reviewing the literature concerning primary treatment showed that, no significant differences were observed in healing of periapical radiolucency between teeth treated in single-visit and those treated in two-visits. Even, after using calcium hydroxide for four weeks . The presence of a positive bacterial culture at the time of filling did not influence the outcome of treatment .

Thorough online search revealed that, few studies are found concerning post- operative pain after single visit retreatment . The present study is designed to compare the effects of single-visit and two-visit root canal treatments on postoperative pain in retreatment cases. The primary outcome measure of this study is proposed to be whether single-visit root canal retreatment influenced the occurrence of postoperative pain as compared to two-visit treatment.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 62
Est. completion date June 2021
Est. primary completion date May 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria:

- Clinically asymptomatic.

- Previously treated teeth in need of retreatment due to leakage and/or improper filling.

- No periapical radiolucency.

- No percussion pains.

- Age 20 - 45.

- Premolar teeth.

- Male & female.

Exclusion Criteria:

- Complicating compromised patient.

- Tenderness to percussion and acute apical abscess.

- Presence of an associated sinus tract.

- Presence of swelling in adjacent soft tissue.

- Teeth with periodontal pathologies or mobility.

- Teeth representing root fracture.

- Pregnant women.

- If analgesics or antibiotics have been administrated by the patient during the past 24 hours.

Study Design


Intervention

Other:
Non-surgical endodontic retreatment in single visit
Full medical and dental history using a schematic dental chart, will be obtained from all patients treated during this study.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

References & Publications (1)

Erdem Hepsenoglu Y, Eyuboglu TF, Özcan M. Postoperative Pain Intensity after Single- versus Two-visit Nonsurgical Endodontic Retreatment: A Randomized Clinical Trial. J Endod. 2018 Sep;44(9):1339-1346. doi: 10.1016/j.joen.2018.05.017. Epub 2018 Jul 24. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and intensity of postoperative Evaluate incidence and intensity of postoperative pain at 6,12,24, 48hours , and one week using numerical visual scale (NRS) after each visit endodontic retreatment At one week after each visit
Secondary Number of analgesic tablets Number of analgesic tablets taken by the patient after endodontic retreatment baseline
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