NCT06694064

Brief Summary

Pediatric dentistry has always debated the benefits of vital pulp therapy. AIM: The current study was done to differentiate the histo-pathological findings of MTA versus grape seed extract in primary teeth undergoing pulpotomy as pulp dressing substances. Materials and Methods: According to the inclusion criteria, 16 primary teeth were selected in each group. Randomly and equally, the teeth were split into two groups: (MTA group) Group I, and (GSE group) Group II. After nine months, under a light microscope the teeth were evaluated and a clinical follow-up was conducted. Periapical radiographs were also taken at this time.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

October 21, 2024

Last Update Submit

November 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • evaluate pain of the teeth

    The lack of any clinical indications of pulp degeneration, such as the history of spontaneous pain, pain on percussion, swelling, pathological mobility, or sinus tract

    6 months

Secondary Outcomes (1)

  • absence of radiolucency

    6 months

Study Arms (2)

Mta group

EXPERIMENTAL

after pulpotomy the pulp stumps subgected to mta material

Procedure: PulpotomyProcedure: extraction for histologic examination

Grape seed group

EXPERIMENTAL

after pulpotomy the pulp stumps subjected to grape seed

Procedure: PulpotomyProcedure: extraction for histologic examination

Interventions

PulpotomyPROCEDURE

Pulpotomy will be done for mta group

Grape seed groupMta group

after pulp therapy the teeth exrtracted for histologic examination

Grape seed groupMta group

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy patients with carious primary molars

You may not qualify if:

  • root resorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alazhar University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Interventions

PulpotomyHistological Techniques

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

EndodonticsDentistryClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of pediatric dentistry

Study Record Dates

First Submitted

October 21, 2024

First Posted

November 19, 2024

Study Start

January 2, 2023

Primary Completion

January 10, 2024

Study Completion

September 2, 2024

Last Updated

November 19, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Individual Participant Data Set Access

Locations