Single and Two-visit Pulpectomy in Primary Molars

Sponsor
Mansoura University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06071663
Collaborator
(none)
32
2
12

Study Details

Study Description

Brief Summary

A total of 64 primary molars of 5-8 years old children will be randomly selected from Pediatric dental clinic at Faculty of Dentistry, Mansoura University.

Children will have two bilateral carious primary molars indicated for pulpectomy ; One side will be treated in one visit and the other will be treated in two visits.

Clinical and radiographic evaluation for 3 , 6, 12 months

Condition or Disease Intervention/Treatment Phase
  • Procedure: Single and two visits pulpectomy
N/A

Detailed Description

All the pulpectomy steps will be carried out by a single operator. After confirming the diagnosis clinically and radiographically, the necrotic tooth will be anesthetized by local anesthesia and isolated by rubber dam.

Caries will be removed by sterile round diamond burs. Proper access cavity will be prepared with complete deroofing and the pulp chamber will be irrigated by saline 0.9%. The working length will be established by apex locator and confirmed by periapical film (1 mm short of radiographic apex). Mechanical instrumentation will be done using rotary files followed by irrigation with no excessive pressure between files using sodium hypochlorite 2.5%. Then, root canal system will be dried by sterile paper points.

In case of single visit pulpectomy (21):

Root canals will be obturated by metapex and the tooth will be finally restored by glass ionomer filling and stainless-steel crown.

In case of two visit pulpectomy (13):

First, root canals will be filled by calcium hydroxide powder mixed with saline followed by temporary coronal restoration and left for 7 days.

In the second visit, calcium hydroxide will be removed from the canals using K -files then irrigated by NaOCL 2.5%. The canals will be dried by sterile paper points before obturation and final restoration as mentioned in single- visit treatment protocol. A postoperative periapical x-ray film will be taken for future review.

Clinical and radiographic follow up will be carried out after 3, 6, 12 months respectively.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical and Radiographic Evaluation of Single-Versus Two-visit Pulpectomy in Primary Molars: Randomized Controlled Clinical Trial
Anticipated Study Start Date :
Oct 5, 2023
Anticipated Primary Completion Date :
Jan 5, 2024
Anticipated Study Completion Date :
Oct 5, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: single visit

Necrotic primary molar treated in single visit

Procedure: Single and two visits pulpectomy
Comparison of clinical and radiographic outcome of Single and two visits pulpectomy

Active Comparator: Two visits

Necrotic primary molar treated in two visits

Procedure: Single and two visits pulpectomy
Comparison of clinical and radiographic outcome of Single and two visits pulpectomy

Outcome Measures

Primary Outcome Measures

  1. Clinical and Radiographic outcomes [3 , 6 and 12 months]

    Proportion of clinical and radiographic success in both treatment protocols

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Cooperative 5-8 years old children with no systemic diseases or chronic conditions. _Every child should have bilateral necrotic primary molars indicated for pulpectomy with sufficient coronal tooth structure.
Exclusion Criteria:
  • Children received antibiotics in the past month before the study. Primary molars with sinus tract, abscess, or facial cellulitis. Primary molas with root resorption exceeding one third of root length

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mansoura University

Investigators

  • Study Director: Nadia Moustafa Fareag, Professor, Pediatric dentistry department. MANSOURA UNIVERSITY

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Moustafa Reda, Sherbin/Dakhlia/Egypt, Mansoura University
ClinicalTrials.gov Identifier:
NCT06071663
Other Study ID Numbers:
  • A0603023PP
First Posted:
Oct 6, 2023
Last Update Posted:
Oct 6, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Moustafa Reda, Sherbin/Dakhlia/Egypt, Mansoura University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2023