Clinical trial NCT06509451: Retention Rate of Giomer Pit and Fissure Sealant Applied With or Without Etching
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Caries Prevention
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 52
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial
Primary purpose: 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)

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

Primary outcomes:
measure: retention rate
timeFrame: 3 months, 6months , 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry, cairo university
Study officials:
affiliation: Cairo University
name: Cairo
role: PRINCIPAL_INVESTIGATOR
References: