Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children

NCT ID: NCT05314660

Last Updated: 2022-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2022-03-15

Brief Summary

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Testing 3 different caries arresting techniques and the quality of life of a group of preschool children in Mansoura city, Egypt.

Detailed Description

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135 preschoolers were allocated randomly into 3 groups to receive 3 techniques to evaluate caries arrestment. The first group received 38% silver diamine fluoride, the second received conventional Atraumatic restorative technique and the third group received ultra consevative treatment (UCT). The subjects were followed up at 3, 6 and 12 months to check caries activity according to the ICDAS.

The parents of the children answered the Arabic ECOHIS before treatment and after 3 months to assess oral health related quality of life.

Conditions

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Caries Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3 equal groups receiving 3 different protocols
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

The operator must know the group in which the participant is enrolled so as to provide and carry out the intended treatment protocol. Randomization was preformed by block randomization by the nurse.

Study Groups

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Silver diamine fluoride group

Application of 38% SDF.

Group Type EXPERIMENTAL

38 % silver diamine fluoride

Intervention Type DRUG

Application of 38% SDF on carious dentine lesions.

Atrumatic restorative technique

Group Type EXPERIMENTAL

Atraumatic restorative technique

Intervention Type PROCEDURE

Hand excavation of carious dentine followed by application of Glass ionomer

Ultra conservative treatment (UCT)

Group Type EXPERIMENTAL

Ultra conservative dentistry

Intervention Type PROCEDURE

Removal of soft dentine and enlarging of cavity to control bio film

Interventions

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38 % silver diamine fluoride

Application of 38% SDF on carious dentine lesions.

Intervention Type DRUG

Atraumatic restorative technique

Hand excavation of carious dentine followed by application of Glass ionomer

Intervention Type PROCEDURE

Ultra conservative dentistry

Removal of soft dentine and enlarging of cavity to control bio film

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* healthy children aged 3-5
* residents of mansoura city
* having at least one carious dentine lesion

Exclusion Criteria

* large carious lesions approximating the pulp
* signs of pulpitis, fistula, abscess.
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Basma Hamza

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

References

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Hamza BE, Attia NM, Abdellatif AM, Hegazy SA. Arresting Active Carious Lesions Using Minimal Intervention Dentistry among a Group of Preschool Children: A Randomized Controlled Clinical Trial. Int J Clin Pediatr Dent. 2024 Sep;17(9):1018-1024. doi: 10.5005/jp-journals-10005-2927.

Reference Type DERIVED
PMID: 39664835 (View on PubMed)

Other Identifiers

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A22080120

Identifier Type: -

Identifier Source: org_study_id

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