NCT04818658

Brief Summary

The aim of this study is to compare the survival rate of the conventional restorations with the Hall Technique in carious primary molars.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

March 24, 2021

Last Update Submit

July 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • The survival rate of Hall Technique and Compomer Restorations

    1. Successful: restoration satisfactory, no additional treatment required, no clinical sign and symptoms of pulpal pathology or tooth exfoliated, 2. Minor failure: restoration wear/fracture/loss (restorable) or crown perforation, secondary caries or new caries, reversible pulpitis treated without requiring extraction or pulpotomy, 3. Major failure: the tooth is broken down (unrestorable), inter-radicular radiolucency or internal root resorption, signs or symptoms of irreversible pulpitis requiring extraction or pulpotomy. 4. The survival analysis: the restorations are assessed as successful or failure.

    5 year

Study Arms (2)

Preformed Metal Crowns using Hall Technique

Other: Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars

Compomer Restoration

Other: Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars

Interventions

Intra-oral clinical examination is performed and restorations are evaluated by the practitioner. Periapical radiography is taken according to national guidelines.

Compomer RestorationPreformed Metal Crowns using Hall Technique

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

patients aged 5-8 years treated with preformed metal crowns using Hall Technique and compomer restoration

You may qualify if:

  • patients aged five to eight years at the time of dental treatment,
  • patients attending follow-up appointments
  • patients with compomer restoration and Hall restoration in their teeth
  • patients with matching the extent of caries in the two groups

You may not qualify if:

  • patients not attending follow-up appointments
  • patients without both treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahcesehir University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Betul Sen Yavuz

    Bahçeşehir University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 26, 2021

Study Start

March 8, 2021

Primary Completion

October 3, 2021

Study Completion

December 10, 2021

Last Updated

July 21, 2022

Record last verified: 2022-07

Locations