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Oral Health-Related Quality of Life of Early Childhood Caries Using Silver Diamine Fluoride Versus Drill and Fill Technique

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05337449
Collaborator
(none)
40
Enrollment
2
Arms
17.5
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The clinical trial aims to compare children's oral health-related quality of life (OHrQL) following caries arrest technique using SDF versus conventional drill and fill in the children with ECC

Condition or Disease Intervention/Treatment Phase
  • Other: silver diamine fluoride
  • Other: conventional composite resin restoration
 N/A

Detailed Description

Early childhood caries (ECC) has been an increasing issue in many countries and has become a significant health problem, especially in socially disadvantaged populations. ECC is a specific form of caries that occurs in children with primary teeth. ECC is characterized as "the early onset of caries in young children with often fast progression which can finally result in complete destruction of the primary dentition".

Management of cavitated carious lesions in primary teeth in very young children is time-consuming due to their lack of cooperation, so one of the alternative procedures could be performed with silver diamine fluoride (SDF), to its effectiveness in arresting the activity of carious lesions (cavitated and non-cavitated). It is easy to apply even outside dental offices, and relatively inexpensive solutions can be used particularly when compared to restorative intervention.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
for both the intervention group and control group, the procedure and follow up will be done parallel to each otherfor both the intervention group and control group, the procedure and follow up will be done parallel to each other
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation Of Changes in Children's Oral Health-Related Quality of Life Following Treatment of Early Childhood Caries With Caries Arrest Technique Using Silver Diamine Fluoride Versus Conventional Drill and Fill Technique A Randomized Clinical Trial
Anticipated Study Start Date :
Jul 15, 2022
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: silver diamine fluoride

Other: silver diamine fluoride
silver diamine fluoride is a colorless with high PH topical fluoride solution of 38% weight/volume use for arresting early childhood caries

Other: conventional composite resin restoration
Dental composite resins are dental cement made of synthetic resins which were insoluble, of good tooth-like appearance, insensitive to dehydration, and easy to manipulate.
Active Comparator: conventional composite resin restoration

Other: silver diamine fluoride
silver diamine fluoride is a colorless with high PH topical fluoride solution of 38% weight/volume use for arresting early childhood caries

Other: conventional composite resin restoration
Dental composite resins are dental cement made of synthetic resins which were insoluble, of good tooth-like appearance, insensitive to dehydration, and easy to manipulate.

Outcome Measures

Primary Outcome Measures

  1. Oral Health to Quality of Life [6 month intervene]

    will be evaluated by a questioner answered by the parents

Secondary Outcome Measures

  1. The cost effectiveness [6 month intervene]

    will be measured using ICER (incremental cost-effectiveness ratio)

  2. Parental satisfaction [6 month intervene]

    will be measured by Direct questioning to the parents.

  3. Side effects [6 month intervene]

    will be measured by Direct questioning to the parents.

  4. Time of the procedure [6 month intervene]

    will be measured by stopwatch

  5. Postoperative pain and sensitivity [6 month intervene]

    will be measured by Visual analogue scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Children Aged 3 to 5 years, in good general health and medically within normal.

  • The parents provided written informed consent.

  • Carious vital primary molars with reversible pulpitis.

  • Restorable teeth.

  • Normal Radiographic findings.

Exclusion Criteria:

  • Unable to attend follow-up visits.

  • Refusal of participation.

  • Previously accessed teeth.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Gala Osman, BDS, Cairo University
  • Study Director: Sherine Younes, Professor, Cairo University
  • Study Director: Passant Nagii, PHD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gala Sharif Osman, principal investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT05337449
Other Study ID Numbers:
  • OHrQL in ECC treated with SDF
First Posted:
Apr 20, 2022
Last Update Posted:
Jun 15, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fluorides

Study Results

No Results Posted as of Jun 15, 2022