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Not yet recruitingNCT06071663Updated Oct 6, 2023

Single and Two-visit Pulpectomy in Primary Molars

An interventional study of Single and two visits pulpectomy in Dental Pulp Necroses, sponsored by Mansoura University. Not yet recruiting. Open to participants aged 5 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-06.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
5 Years to 8 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Dental Pulp Necroses

Keywords

  • Pulpectomy, single visit, two visits
03

Who can participate

Ages eligible
5 Years to 8 Years
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • Active comparator
    single visit

    Necrotic primary molar treated in single visit

    Procedure: Single and two visits pulpectomy

  • Active comparator
    Two visits

    Necrotic primary molar treated in two visits

    Procedure: Single and two visits pulpectomy

Interventions

  • ProcedureSingle and two visits pulpectomy

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

05

What researchers measure

Primary outcomes

  1. Clinical and Radiographic outcomes

    Proportion of clinical and radiographic success in both treatment protocols

    Time frame: 3 , 6 and 12 months

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06071663
Lead sponsor
Mansoura University
Responsible party
Moustafa Reda (Sherbin/Dakhlia/Egypt, Mansoura University) — Principal investigator
First posted
Oct 6, 2023
Start date
Oct 5, 2023 (estimated)
Primary completion
Jan 5, 2024 (estimated)
Completion
Oct 5, 2024 (estimated)
Last update
Oct 6, 2023

Study contacts

Moustafa Omar, Bachelor of Dentistry
Contact
ahmedwael241014@gmail.com
01062685288
Mahmoud Mahmoud Shaaban, Bachelor of Dentistry
Contact
01012342048
Nadia Moustafa Fareag, Professor
study director · Pediatric dentistry department. MANSOURA UNIVERSITY

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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