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Retention Rate of Giomer Pit and Fissure Sealant Applied With or Without Etching

Retention Rate of Giomer S-PRG Filler Containing Pit and Fissure Sealant Applied With or Without Etching by Using Split Mouth Technique: Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06509451
Enrollment
52
Registered
2024-07-19
Start date
2023-05-01
Completion date
2024-08-01
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries Prevention

Brief summary

The aim of this study is to evaluate the retention rate of Giomer S-PRG filler containing pit and fissure sealant applied with or without etching by using split mouth technique.with null hypothesis that Giomer S-PRG filler containing pit and fissure sealant applied either with or without etching will have the same retention rate.

Detailed description

Study Settings: The study will be carried out at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University in Egypt. Ethical approval is taken from the Research Ethics Committee of the faculty of Dentistry, Cairo University. Signed informed consent is signed by each participant. Recruitment: Participants are recruited from the patients' flow at the clinics of the Conservative Dentistry Department of Faculty of Dentistry, Cairo university. Eligibility Criteria: Inclusion Criteria: 1. ICDAS score 0 or 1 2. Satisfactory oral hygiene 3. Normal salivary characteristics (consistency, pH, flow rate, buffering capacity) 4. Satisfactory cooperative behavior 5. Age between 15- 30 years old 6. Males or females 7. Subjects who signed informed consent Exclusion Criteria: 1. ICDAS score \> 1 2. Poor oral hygiene 3. Evidence of tempromandibular joint disorders or malocclusion Materials used in this trial are the Giomer S-PRG filler containing pit and fissure sealant (Beautisealant) and its self etching primer (Beauisealant primer). Control group: In the control group, an adequate amount of primer will be applied onto the enamel surface with a microbrush, left undisturbed for 5 s and then air-dried gently to avoid blowing it away. Beautisealant will be applied directly from the syringe into pits and fissures and light-cured for 10 s, according to the manufacturer's instructions. Intervention Group: In the intervention group, the same steps will be done except for an additional initial etching step with phosphoric acid etching for 30 s (for the uncut enamel) before primer and sealant application. Outcome Assessment: The results of sealant retention were assessed according to the following criteria (Simonsen): A complete retention B partial loss (B1, without caries; B2, with caries) C complete loss (C1, without caries; C2, with caries)

Interventions

DRUGGiomer pit and fissure sealant without etching

S-PRG filler containig pit and fissure sealant without etching step

DRUGGiomer pit and fissure sealant with etching

S-PRG filler containig pit and fissure sealant with etching step

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
15 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

1. ICDAS score 0 or 1 2. Satisfactory oral hygiene 3. Normal salivary characteristics (consistency, pH, flow rate, buffering capacity) 4. Satisfactory cooperative behavior 5. Age between 15- 30 years old 6. Males or females 7. Subjects who signed informed consent

Exclusion criteria

1. ICDAS score \> 1 2. Poor oral hygiene 3. Evidence of tempromandibular joint disorders or malocclusion

Design outcomes

Primary

MeasureTime frameDescription
retention rate3 months, 6months , 1 yearTo assess the sealant retention rate either total retention, partial loss or total loss

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026