PITS AND FISSURE SEALANTPhase 3NCT05791682
"Comparative Clinical Evaluation of Pit and Fissure Sealants on Permanent First Molar Teeth in Children."
A Phase 3 study testing Sealant, Fissure in people with PITS AND FISSURE SEALANT, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Study was aimed to evaluate and compare clinical efficacy of the Microfilled resin sealant, Nanofilled resin sealant, Flowable composite as sealant, with Unfilled resin sealant on first permanent molar in children at 9 months follow ups. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- PITS AND FISSURE SEALANT
- What is being tested?
- Sealant, Fissure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIndia
- Study dates
- 2 Apr 2021to 5 Nov 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Normal healthy children aged 7 to 10 years.
- Subjects who are not undergoing any other preventive dental health treatment.
- Availability for the duration of the study.
- Satisfactory dental care performed at home.
- The willingness of the patient to accept the treatment.
- All four first permanent molars that have completely erupted with deep pits and fissures.
- Fissures either intact, sound or retentive which are stained, caries free or ICDAS 0-2.
Who cannot join
- Children whose parents will not give informed consent.
- Special child, a child with compromised systemic health.
- Long-term medication affecting the salivary flow.
- Children enrolled for other studies or fluoridation program.
- Adverse reaction reported to any dental material.
- Uncooperative child.
Show all 10Show fewer
- Bruxism or malocclusion.
- Children with developmental defects/ hypoplastic molars or caries affected teeth (ICDAS>2).
- Teeth with restoration and partially retained sealants.
- Children who cannot come for the follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Comparative Clinical Evaluation of Microfilled Resin Sealant, Nanofilled Resin Sealant and Flowable Composite as Sealant With Unfilled Resin Sealant on Permanent First Molar Teeth in Children."
Study was aimed to evaluate and compare clinical efficacy of the Microfilled resin sealant, Nanofilled resin sealant, Flowable composite as sealant, with Unfilled resin sealant on first permanent molar in children at 9 months follow ups.
Children (age 7 to 10) with deep pits and fissures, (ICDAS 0-2) included in the study and study was Split mouth randomized controlled clinical trial.
Read more
Sample size- Total number of 42 patients will be recruited in the study, with 42 first permanent molars in each group.
Methods-Patients were seated in supine position on the dental chair and cotton rolls will be applied for isolation. The first permanent molar in each group was treated as follows:
Group 1 -Intervention with Microfilled resin sealant. Group 2- ¬Intervention with Nanofilled resin sealant. Group 3 -Intervention with Flowable composite as sealant. Group 4 - ¬Intervention with Unfilled resin sealant. Patients and their parents were received instructions for daily brushing and oral hygiene maintenance. Sealant clinical efficacy was evaluated at 3, 6 and 9 month recall visit.
OUTCOME MEASURES:
- Primary outcomes: To evaluate sealant retention, anticaries effect and marginal integration.
- Secondary outcomes: to evaluate, colour change and surface roughness of sealant.
- Conditions
- PITS AND FISSURE SEALANT
- Being tested
- Sealant, Fissure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sealant, FissureDrug
FISSURIT FX- MICROFILLED RESIN SEALANT WITH 55% FILLER GRANDIOSEAL- NANOFILLED RESIN SEALANT WITH 70% FILLER TE-ECONOM- FLOW -FLOWABLE COMPOSITE AS SEALANT CLINPRO TM- UNFILLED RESIN SEALANT
| Study group | Role | What they receive |
|---|---|---|
| MICROFILLED RESIN SEALANT | Active comparator | -Microfilled rein sealant (fissurit FX) after etching, washing, drying, sealant was gradually applied along the fissure of first permanent molar, Immediately light cured for 20 sec Receives: Drug: Sealant, Fissure |
| NANOFILLED RESIN SEALANT | Active comparator | Nanofilled resin sealant (Grandioseal) after etching, washing, drying, sealant was gradually applied along the fissure. Immediately light cured for 20 sec. Receives: Drug: Sealant, Fissure |
| FLOWABLE COMPOSITE | Active comparator | Flowable composite (Te-Econom Flow) after etching, washing, drying, adhesive was applied and dried under gentle air flow for 2-3 sec and was light cured. A uniform layer of flowable composite was applied and light cure for 20 sec. Receives: Drug: Sealant, Fissure |
| UNFILLED RESIN SEALANT | Active comparator | Unfilled resin sealant (clinpro) after etching, washing, drying, sealant will be gradually applied along the fissure. Immediately light cure for 20 sec. Receives: Drug: Sealant, Fissure |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate sealant retention
Alpha - complete retention Bravo- partial retention Charlie- no retention
Measured: 9 months
Secondary outcomes (4)
To evaluate marginal integrity
Alpha- No visible evidence of a crevice along the margin of the sealant that the explorer could penetrate.
Bravo- Visible evidence of a crevice along the margin of the sealant that the explorer could penetrate.
Measured: 9 months
to evaluate anti caries effect
Alpha- Sound fissures. Bravo- Fissures with caries.
Measured: 9 months
to evaluate colour change
Alpha- No discoloration anywhere on the margin around the sealant. Bravo- Visible partial discoloration the margin around sealant. Charlie- Visible discoloration on the margin around all sealant.
Measured: 9 months
to evaluate surface roughness
Alpha- The sealant is similar to polished enamel. Bravo- The sealant surface is similar to composite material surface contained submicron filler.
Charlie- The surface is rough that prevents the explorer movement along the surface.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start2 Apr 2021
- Primary completion3 Oct 2022
- Study completion5 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PITS AND FISSURE SEALANTStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791682
- Sponsor's protocol ID
- PGIDS/BHRC/21/14
- Status last verified
- Mar 2023
- First submitted
- 12 Nov 2022
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparative Clinical Evaluation of Microfilled Resin Sealant, Nanofilled Resin Sealant and Flowable Composite as Sealant With Unfilled Resin Sealant on Permanent First Molar Teeth in Children."
- ClinicalTrials.gov ID
- NCT05791682
- Acronym / sponsor ID
- PGIDS/BHRC/21/14
- Conditions
- PITS AND FISSURE SEALANT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study was aimed to evaluate and compare clinical efficacy of the Microfilled resin sealant, Nanofilled resin sealant, Flowable composite as sealant, with Unfilled resin sealant on first permanent molar in children at 9 months follow ups.
Children (age 7 to 10) with deep pits and fissures, (ICDAS 0-2) included in the study and study was Split mouth randomized controlled clinical trial.
Sample size- Total number of 42 patients will be recruited in the study, with 42 first permanent molars in each group.
Methods-Patients were seated in supine position on the dental chair and cotton rolls will be applied for isolation. The first permanent molar in each group was treated as follows:
Group 1 -Intervention with Microfilled resin sealant. Group 2- ¬Intervention with Nanofilled resin sealant. Group 3 -Intervention with Flowable composite as sealant. Group 4 - ¬Intervention with Unfilled resin sealant. Patients and their parents were received instructions for daily brushing and oral hygiene maintenance. Sealant clinical efficacy was evaluated at 3, 6 and 9 month recall visit.
OUTCOME MEASURES:
- Primary outcomes: To evaluate sealant retention, anticaries effect and marginal integration.
- Secondary outcomes: to evaluate, colour change and surface roughness of sealant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MICROFILLED RESIN SEALANT | Active comparator | Drug: Sealant, Fissure-Microfilled rein sealant (fissurit FX) after etching, washing, drying, sealant was gradually applied along the fissure of first permanent molar, Immediately light cured for 20 sec |
| NANOFILLED RESIN SEALANT | Active comparator | Drug: Sealant, FissureNanofilled resin sealant (Grandioseal) after etching, washing, drying, sealant was gradually applied along the fissure. Immediately light cured for 20 sec. |
| FLOWABLE COMPOSITE | Active comparator | Drug: Sealant, FissureFlowable composite (Te-Econom Flow) after etching, washing, drying, adhesive was applied and dried under gentle air flow for 2-3 sec and was light cured. A uniform layer of flowable composite was applied and light cure for 20 sec. |
| UNFILLED RESIN SEALANT | Active comparator | Drug: Sealant, FissureUnfilled resin sealant (clinpro) after etching, washing, drying, sealant will be gradually applied along the fissure. Immediately light cure for 20 sec. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Normal healthy children aged 7 to 10 years.
- Subjects who are not undergoing any other preventive dental health treatment.
- Availability for the duration of the study.
- Satisfactory dental care performed at home.
- The willingness of the patient to accept the treatment.
Key exclusion criteria (10 listed)
- Children whose parents will not give informed consent.
- Special child, a child with compromised systemic health.
- Long-term medication affecting the salivary flow.
- Children enrolled for other studies or fluoridation program.
- Adverse reaction reported to any dental material.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sealant, FissureFISSURIT FX- MICROFILLED RESIN SEALANT WITH 55% FILLER GRANDIOSEAL- NANOFILLED RESIN SEALANT WITH 70% FILLER TE-ECONOM- FLOW -FLOWABLE COMPOSITE AS SEALANT CLINPRO TM- UNFILLED RESIN SEALANT | Drug | FLOWABLE COMPOSITE, MICROFILLED RESIN SEALANT, NANOFILLED RESIN SEALANT, UNFILLED RESIN SEALANT |
Primary outcome
To evaluate sealant retention
Time frame: 9 months
Alpha - complete retention Bravo- partial retention Charlie- no retention
4 secondary outcomes
To evaluate marginal integrity
Time frame: 9 months
to evaluate anti caries effect
Time frame: 9 months
to evaluate colour change
Time frame: 9 months
to evaluate surface roughness
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
Related trials for PITS AND FISSURE SEALANT
RecruitingObservational study
Retention of Pits and Fissure Sealants on Non Carious vs Initial Carious Enamel Lesions in Posterior Teeth
Dental Enamel, Dental Enamel Hypomineralization
Not yet recruiting
A Comparative Evaluation of the Role of Self-Adhesive Flowable Composite in Enhancing Sealant Retention Versus Conventional Pits and Fissure Sealant With and Without Fissurotomy in Permanent Molars
Pits and Fissure Sealants
Not yet recruiting
Wear Resistance Of Bioactive With And Without Etching Vs. Conventional Resin-Based Fissure Sealants
Pit and Fissure Caries
Recruiting
Ozone Application Before Fissure Sealants
Caries,Dental
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sealant, Fissure in people with PITS AND FISSURE SEALANT, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate sealant retention (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.