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Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials

Primary Purpose

Post Operative Pain

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Metapex

Endoflas

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

5 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

3.1. Inclusion criteria: The study will include children who meet the following clinical and radiographic criteria:

Clinical:

5-7-year old children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.
Children rated as no.3 or 4 in Frankel behavior rating scale (FBRS).
Presence of at least one primary molar with deep carious lesion.
Asymptomatic necrotic molars confirmed by the absence of bleeding on opening of the pulp chamber.

Radiographic:

Extensive caries approaching to the pulp.
Presence of at least two-thirds of root length.

Exclusion Criteria:

A child's tooth with any of the following criteria:

Clinical findings:

History of spontaneous unprovoked toothache.
Extensive crown destruction that preclude coronal restoration.
Presence of adjacent or opposing tooth with deep carious lesion "in the same side".
History of administering analgesics 12 hours before tooth obturation.

Radiographic findings:

Presence of a large furcation or periapical radiolucency approximating the succedaneous tooth.
Presence of pathological internal/external root resorption.
Absence of underlying permanent successor.

Sites / Locations

Nada Mohamed Hassan SaiedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Metapex group

Endoflas group

Arm Description

Obturation of primary molars with calcium hydroxide and iodoform paste

Obturation of primary molars with calcium hydroxide, eugenol and iodoform paste

Outcomes

Primary Outcome Measures

postoperative pain.

Measuring post operative pain after pulpectomy with two different obturation materials using (Modified Wong-backer scale of pain )which have four scales from( 0 to 3) which 0 is the better outcome( no pain) and 3 is the worst (severe pain).

Secondary Outcome Measures

Full Information

NCT ID

NCT05475795

First Posted

July 24, 2022

Last Updated

July 31, 2022

Sponsor

Minia University

1. Study Identification

Unique Protocol Identification Number

NCT05475795

Brief Title

Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials

Official Title

Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials: A Parallel Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 9, 2022 (Actual)

Primary Completion Date

December 15, 2022 (Anticipated)

Study Completion Date

January 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Testing postopertive pain after pulpectomy of primary molars with Metapex and Endoflas using modified Wong-Baker scale of pain.

Detailed Description

The current equivalent parallel randomized controlled trial will be conducted to evaluate intensity and duration of post-operative pain after pulpectomy of asymptomatic necrotic primary molars, using Metapex and Endoflas obturation materials

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Operative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Metapex group

Arm Type

Active Comparator

Arm Description

Obturation of primary molars with calcium hydroxide and iodoform paste

Arm Title

Endoflas group

Arm Type

Experimental

Arm Description

Obturation of primary molars with calcium hydroxide, eugenol and iodoform paste

Intervention Type

Other

Intervention Name(s)

Metapex

Intervention Description

obturation of root canals of primary molars with Metapex

Intervention Type

Other

Intervention Name(s)

Endoflas

Intervention Description

obturation of root canals of primary molars with Endoflas

Primary Outcome Measure Information:

Title

postoperative pain.

Description

Time Frame

after one day and after one week .

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 3.1. Inclusion criteria: The study will include children who meet the following clinical and radiographic criteria: Clinical: 5-7-year old children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale. Children rated as no.3 or 4 in Frankel behavior rating scale (FBRS). Presence of at least one primary molar with deep carious lesion. Asymptomatic necrotic molars confirmed by the absence of bleeding on opening of the pulp chamber. Radiographic: Extensive caries approaching to the pulp. Presence of at least two-thirds of root length. Exclusion Criteria: A child's tooth with any of the following criteria: Clinical findings: History of spontaneous unprovoked toothache. Extensive crown destruction that preclude coronal restoration. Presence of adjacent or opposing tooth with deep carious lesion "in the same side". History of administering analgesics 12 hours before tooth obturation. Radiographic findings: Presence of a large furcation or periapical radiolucency approximating the succedaneous tooth. Presence of pathological internal/external root resorption. Absence of underlying permanent successor.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Osama S Gad El-Hak

Phone

00201023449797

osama.seif@mu.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Osama S Gad El-Hak, PhD

Organizational Affiliation

Pediatric Dentistry Department, Faculty of Dentistry, Minia University

Official's Role

Study Director

Facility Information:

Facility Name

Nada Mohamed Hassan Saied

City

Minya

ZIP/Postal Code

61511

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nada M Hassan

Phone

00201116889844

nadooshaa66@gmail.com

12. IPD Sharing Statement

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Postoperative Pain After Pulpectomy of Primary Molars Using Different Obturation Materials

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