Clinical trial NCT06157021: Obturation Quality in Primary Molars
Official title: Evaluation of Obturation Quality in Necrotic Primary Molars After Manual Versus Rotary Pulpectomy; a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Necrotic Primary Molars
Keywords: Rotary instrumentation
pulpectomy
primary molars
obturation quality
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled parallel double blinded study
Primary purpose: TREATMENT

Brief summary: Forty cases of necrotic primary molars in children aged 4-8 years were selected to compare the effect of manual versus rotary pulpectomy regarding parental acceptance and obturation quality.

Detailed description: The present study was performed in the Department of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egypt.

Ethical approval was obtained from the Ethical Committee board of Faculty of Dentistry, Cairo University, Egypt.

Written informed consent was taken from the legal guardian of each participating child willing to participate in the trial, prior to the start of the clinical procedure after explaining the whole procedure in a simple way. The consent form was written in Arabic.

A sample of 40 primary mandibular second molars of children between 4 and 8 years of age indicated for pulpectomy participated in this double-blinded randomized controlled trial. Parallel allocation design was adopted for the intervention and control arms with allocation ration 1: 1 (i.e. 20 cases each). The sample size was calculated considering the previously published studies with 95% power in detecting the true statistical significance among the two groups.

Control group one: Manual pulpectomy using) H files, Mani\*) Group two: Rotary pulpectomy using (Fanta baby\* rotary files and Endo Radar\* rotary device).

Diagnosis:

Diagnostic chart was filled with personal, medical and dental history.

1. Intra \& extra oral examination was made with aid of mirror and probe to assess the clinical inclusion criteria.
2. Preoperative photographs were taken
3. Preoperative radiograph were examined

Intervention:

Patients were assigned into two groups; Group A (Experimental group) (using rotary files)

1. Pre-operative radiograph showing all roots and their apices.
2. Local anaesthetic (to enable use of rubber dam clamp).
3. Rubber dam isolation.
4. Removal of caries.
5. Removal of roof of pulp chamber.
6. Identify root canals.
7. Irrigate with concentrated sodium hypochlorite followed by normal saline (0.9%)
8. Estimate working lengths of root canals keeping 2 mm short of the radiographic apex.
9. Insert rotary files into canals and debride the canals lightly and gently.
10. Irrigate the root canals.
11. Dry canals with pre-measured paper points, keeping 2 mm from root apices.
12. Canals were dried with paper points, obturated by injecting Metapex. (Meta Biomed - Metapex Root Canal Filling Material)
13. Stainless steel crown was performed

Group B (control group) (using manual files) All steps as that of group A were done except step (j) instead of it; a manual files were inserted into the canals for debridement lightly and gently.

Randomization \&Allocation concealment:- Sequence generation Simple randomization was done by computer software (www.random.com) for patient's assignment in each group.

Blinding:

Blinding to the child participants and legal guardian of each participating child, inter examiner and statistician.

Statistical analysis:

Categorical data were presented as frequencies (n) and percentages (%). Intergroup comparisons were done utilizing Fisher's exact test. while intragroup comparisons were done utilizing Cochran's Q tests followed by Dunn's post hoc test. Ordinal data were presented as median and interquartile range values and were analyzed using Mann-Whitney U test for intergroup comparisons. The significance level was set at p ≤ 0.05 for all tests. Statistical analysis was performed with ® SPSS® (SPSS Inc., IBM Corporation, New York, USA) Statistics Version 26 for Windows.

Eligibility criteria: Inclusion Criteria:

* Medically free children.
* Age: 4-8 years
* Primary molars with necrotic pulp, abscess or fistula.
* Teeth which if lost possibility of space maintainer construction exists.
* Pre-operative radiograph showing absence of root resorption more than one third of the root.

Exclusion Criteria:

* Vital primary teeth.
* Teeth with inadequate tooth structure to support the rubber dam.
* Expected shedding time within one year.
* Peri-radicular involvement extending to the permanent tooth bud.
* Excessive internal\& external root resorption,
* Perforation of pulpal floor.
* Extensive tooth mobility

Primary outcomes:
measure: parental acceptance
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: obturation quality
timeFrame: Immediately after the intervention and after 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo university
Study officials:
affiliation: Faculty of Dentistry, Cairo University, Egypt.
name: Rasha A Ragab, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: