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

NCT06714305 | Completed FDA Device

• 1 other identifier: CPSP/REU/2014-077-1257
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irreversible Pulpitis (toothache)

Outcome Measures

Primary Outcomes (1)

• To compare the effectiveness of manual versus rotary instrumentation for pulpectomy in primary second molar teeth irreversible pulpitis

  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

Study Arms (2)

Group A will be assigned to hand instrumentation.

ACTIVE COMPARATOR

the canal will be prepared by hand hedstorm files, manually by step back technique.

Device: will be assigned to rotary instrumentation.

rotary instrumentation of primary second molar tooth

EXPERIMENTAL

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.

Interventions

Group B will be assigned to rotary instrumentation. DEVICE

group B, NiTi rotary protaper system will be used for canal preparation by crown down technique.

rotary instrumentation of primary second molar tooth

will be assigned to rotary instrumentation. DEVICE

the canal will be prepared by conventional hedstorm files manually by step back technique.

Group A will be assigned to hand instrumentation.

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• RANA AHMAD: lead

Study Sites (1)

Nishter Institute of Dentistry

Multan, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator, Assistant professor (Clinical), Depatment of Operative dentistry, School of dentistry

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 3, 2024
• Study Start: November 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 31, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

PA (1)