Clinical Evaluation of Contemporary Ion Releasing Restorative Materials in Primary Molars Subjected to Selective Caries Removal: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Akdeniz University
- Enrollment
- 86
- Locations
- 2
- Primary Endpoint
- Clinical evaluation of the filling materials according to the modified USPHS criteria
Study Overview
Brief Summary
This randomized controlled trial aims to compare the clinical effectiveness of four ion-releasing restorative materials in the proximal cavities of primary molars that underwent selective caries removal. The main questions to answer are:
- Will there be any difference among the restorative materials clinical succes in the means of modified United States Public Health Services (USPHS) criteria for dental restorations?
- Will there be any difference among the restorative materials in the means of preservation of pulpal vitality? Eighty six children (262 teeth), between 5 and 9 years old (7.15±1.14) enrolled for the study. Researchers will compare the clinical performance of restorative materials, (1:Equia Forte HT; 2: Fuji II LC; 3: Cention N; 4: ChemFil Rock), applied to the proximal cavities of primary molars following selective caries removal, according to the modified USPHS criteria.
Participants will:
- visit the clinic 1st,3rd,6th,12th,18th,24th,30th and 36th months after the restoration.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
The materials were visually different from each other, which allowed the investigators to identify each material. As a result, masking could only be performed with the participants.
Eligibility Criteria
- Ages
- 5 Years to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •For participants:
- •no known or suspected history of allergy to medications or restorative materials
- •no habits of teeth grinding or clenching
- •presence of at least one interproximal carious lesion
- •carious lesion reaching at least 1/2 dentin
- •in contact with adjacent teeth and in occlusion with antagonist teeth
- •have no pathological mobility
- •periodontally healthy
- •no symptoms of pulpal pathology
- •physiological root resorption should not exceed one-third of the root length if seen
- •permanent tooth germ present below the tooth
Exclusion Criteria
- •did not attend their follow-up appointments
Outcomes
Primary Outcomes
Clinical evaluation of the filling materials according to the modified USPHS criteria
Time Frame: Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months.
Restorations were evaluated for retention, marginal discoloration, marginal adaptation, color stability, secondary caries, and postoperative sensitivity according to the modified USPHS with scores assigned as follows: the best being Alpha and the worst being Charlie. Each restoration received a score of Alpha, Bravo, or Charlie at each time interval.
Secondary Outcomes
- Preservation of pulpal vitality(Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months.)
Investigators
Zulfikar Zahit Ciftci
Head of Pediatric Dentistry
Akdeniz University