Treatment of Infected Pulp in Primary Teeth With a Mixture of Calcium Hydroxide and Gingerols

NCT05181813 | Completed

• 1 other identifier: 06030718
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to evaluate Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp

Conditions

Primary Teeth; Pulp Necroses; Infected Pulp; Root Canal Treatment

Keywords

Pediatric Dentistry; Pulpectomy; Infected Pulp; Necrotic Pulp; Gingerols; Calcium Hydroxide; Metapex; Ginge-Cal

Outcome Measures

Primary Outcomes (2)

• Percentage of primary teeth with control necrotic pulp by clinical examination

  The primary outcome was evaluated using clinical evaluation methods. Two pediatric dentists who are blind to treated teeth will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two. Clinical success will be judged to have occurred when there are no reports of pain, abscess, fistula, or mobility inconsistent with chronological age.

  Up to 18 months

• Percentage of primary teeth with control necrotic pulp by radiographic examination

  The primary outcome was evaluated using Radiographic evaluation methods. Two pediatric dentists who are blind to treated teeth will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two. Radiographic success will be evidenced by a decrease or absence of periapical or furcation area radiolucency and pathological root resorption

  Up to 18 months

Study Arms (2)

Group 1: Ginge-Cal group:

EXPERIMENTAL

primary molars were filled by creamy mixture pulpectomy paste of Gingerols and Calcium Hydroxide.

Procedure: Ginge-Cal

Group 2: Metapex group

ACTIVE COMPARATOR

primary molars were filled by a ready-made injectable creamy mixture pulpectomy paste of Metapex

Procedure: Metapex

Interventions

Ginge-Cal PROCEDURE

Fill the infected root canal of of primary teeth with Gingerols extract and Calcium Hydroxide (Ginge-Cal)

Group 1: Ginge-Cal group:

Metapex PROCEDURE

Fill the infected root canal of of primary teeth with Metapex

Group 2: Metapex group

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The cooperation of the child and parents, during the treatment plan, and the commitment to attend the follow-up appointments.
• Parents signed the consent to participate in the study.
• Absence of any systemic disease, which would contraindicate pulp therapy.
• Child didn't have any history of a sensitive reaction to any component of used materials.
• Present half to two third of tooth root or more
• Root with signs or symptoms of infected necrotic pulp or chronic abscess, with or without sinus tract, soft tissue swelling, mobility or tenderness to percussion, and internal or external root resorption or unsuccessful past pulp treatment.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Publications (1)

• Qasem FA, Awad SM, Elagamy RA. Effectiveness of Calcium Hydroxide and Gingerols Mixture as a Novel Obturation Material for Infected Root in Primary Teeth: A Randomized Clinical Trial. Int J Dent. 2024 Feb 8;2024:5528260. doi: 10.1155/2024/5528260. eCollection 2024.

  PMID: 38362239 DERIVED

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Metapex

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fathi A Qasem, PhD

  Assistant Professor of Pediatric Dentistry Faculty of Dentistry Thamar University Yemen

  PRINCIPAL INVESTIGATOR

• Salwa M Awad, Prof

  Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University

  STUDY DIRECTOR

• Rizk A ELagamy, PhD

  Lecturer of Pediatric Dentistry Faculty of Dentistry Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Pediatric Dentistry, Pediatric Dentistry Department

Model Details: Selected children will be divided randomly into 2 groups: Group 1: Ginge-Cal group: primary molars were filled with a creamy mixture of pulpectomy paste of Gingerols and Calcium Hydroxide. Group 2: Metapex group: primary molars were filled with a ready-made injectable creamy mixture pulpectomy paste of Metapex.

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: January 6, 2022
• Study Start: October 17, 2020
• Primary Completion: April 30, 2022
• Study Completion: August 30, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 6 Months
• Access Criteria: For anyone

Locations

EG (1)