Comparison of Effectiveness of Hand Versus Rotary Instrumentation in Pulpectomy of Primary Second Molar Teeth.

December 2, 2024 updated by: RANA AHMAD
To provide an effective technique for pulpectomy in primary second molar teeth in pakistani population, local studies are required. No local studies have been done so far and limited number of international in vivo studies have been conducted previously. Hence this study will evaluate the effectiveness of this technique in pakistani population. If results of this study will be significant in favor of this technique, it will be applied with confidence in same population. There will be better compliance of patients as procedure will be done in single visit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Multan, Punjab, Pakistan
        • Nishter Institute of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Children of both genders having age 4-6.5 years
  2. Children having signs and symptoms of irreversible pulpitis in their second primary molar teeth on clinical examination as per operational definition.

Exclusion Criteria:

  1. Children having previously accessed pulpectomy assessed clinically and on periapical radiographs.
  2. Children having acute/chronic abcesses in teeth under consideration seen clinically.
  3. Children having furcal or periapical radiolucency around teeth under consideration seen on periapical radiograph.
  4. Diabetic, haemophilic or medically compromised children found on history
  5. Children who fail to attend appointments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A will be assigned to hand instrumentation.
the canal will be prepared by hand hedstorm files, manually by step back technique.
Device: will be assigned to rotary instrumentation.
the canal will be prepared by conventional hedstorm files manually by step back technique.
Experimental: rotary instrumentation of primary second molar tooth
NiTi rotary protaper system will be used for canal preparation by crown down technique in primary second molar tooth
Device: Group B will be assigned to rotary instrumentation.
group B, NiTi rotary protaper system will be used for canal preparation by crown down technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the effectiveness of manual versus rotary instrumentation for pulpectomy in primary second molar teeth irreversible pulpitis
Time Frame: immediately after obturation
Effectiveness of instruments will be determined by analyzing the adequacy of root canal filling. Adequacy will be checked immediately after root canal filling on periapical radiographs by measuring with scale the distance of root canal filling from apex to length of filling material in both mesial and distal roots. If distance is less than 2.5 mm, it will be called as effective.
immediately after obturation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RANA AHMAD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Actual)

December 3, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPSP/REU/2014-077-1257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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