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Clinical Trials/CTRI/2024/04/065848
CTRI/2024/04/065848CompletedPhase 4

Comparative assessment of different obturating methods in primary teeth using digital radiography: an in vivo study.

Department of Pediatric and Preventive Dentistry1 site in 1 country120 target enrollmentStarted: April 25, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
Quality of Obturation and presence of voids

Study Overview

Brief Summary

AIM

To compare and assess different obturation  techniques  in primary teeth using digital radiography.

OBJECTIVES

1.     To assess the efficacy of different obturation  techniques  in primary teeth using digital radiography.

2.     To compare the efficacy of different obturation  techniques  in primary teeth using digital radiography.

MATERIALS AND METHODS

Study design â€“ Single Blinded Randomized Clinical trial

Study subjects â€“ Children between the age group of 5-8 years

Sample size â€“ 120 canals

Sample selection: The study sample will include children between the age group of 5-8 years with carious deciduous molar teeth visiting the department of Pediatric and Preventive Dentistry.

Group I – Tuberculin syringe with metal tip

Group II: Tuberculin syringe with plastic tip.

Group III: Lentulo-spiral

Group IV: Past inject carrier

CRITERIA FOR SAMPLE SELECTION –

INCLUSION CRITERIA:

1.    Primary molar indicated for pulpectomy among the children of either sex ranging between 5-8 years of age.

2.    Radiographically teeth with 2/3rd root remaining.

EXCLUSION CRITERIA:

1.     Teeth with caries extending to the furcation.

2.     Root canals with evidence of internal or external resorption

3.     Developmental tooth anomalies

4.     Children with any systemic disease

PROCEDURE â€“

A total sample of 120 canals of primary molar teeth with 2/3rd of root length will be selected which require pulpectomy and will be randomly allocated using chit system into four different obturating techniques, i.e., Group I: Tuberculin syringe with metal tip, Group II: Tuberculin syringe with plastic tip, Group III: Lentulo-spiral, and Group IV: Past inject carrier. Under isolation with rubber dam access cavity will be prepared in each tooth and the infected necrotic pulp tissue will be removed. Working length will be determined and established 1 mm short of the radiographic apex. Biomechanical preparation of the canals will be done till 35 K-file (21 mm). The canals will be repeatedly irrigated alternatively with 1% sodium hypochlorite solution and saline. After instrumentation is complete, the root canals will be dried using absorbent paper points. Post this, all canals will be obturated with Endoflas using the obturating technique assigned to that individual root canal. The quality of obturation, density and presence or absence of voids will be evaluated using digital radiography.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Investigator Blinded

Eligibility Criteria

Ages
5.00 Year(s) to 8.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Primary molar indicated for pulpectomy among the children of either sex ranging between 5-8 years of age.
  • Radiographically teeth with 2/3rd root remaining.

Exclusion Criteria

  • Teeth with caries extending to the furcation.
  • Root canals with evidence of internal or external resorption
  • Developmental tooth anomalies
  • Children with any systemic disease.

Outcomes

Primary Outcomes

Quality of Obturation and presence of voids

Time Frame: Quality of Obturation and presence of voids at baseline.

Secondary Outcomes

  • Technique with best quality of obturation which is easier for the operator & well accepted for the child.(During obturation of the teeth at baseline.)

Investigators

Sponsor
Department of Pediatric and Preventive Dentistry
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Mansi Baviskar

Dr. D.Y. Patil Deemed to be University, School of Dentistry, Navi Mumbai.

Study Sites (1)

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