Incipient Enamel CariesNCT03130725
Retention of Bonded Amalgam Sealants Versus Resin-based Sealants
A study testing Amalgam sealant and Resin based sealant in people with Incipient Enamel Caries and Fissure, Dental, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Dental caries, is one of the major public health problem in Pakistan. Dental sealants are known cost effective preventive measure of dental caries as compared to other preventive measures. Resin based sealants, is a proven treatment of pits and fissure sealants but retention is still problem. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Incipient Enamel Caries, Fissure, Dental
- What is being tested?
- Amalgam sealant and Resin based sealant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2017to 1 Oct 2017
- Phase
- Interventional
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of aged 12 to 16 years (male and female) who will visit to the study site and fulfilled the eligibility criteria
- Teeth should be caries free at the time of sealants placement. As Dental sealant is a preventive treatment it is placed in a caries free surface. Incipient carious lesions will also be included.
- Teeth should be completely erupted, as incomplete eruption of teeth is highly correlates to the partial retention of sealants.
- Children who will give assent to participate in a study and their parents will give consent.
Who cannot join
- Special needs children (because they need special attention of parents)
- Children who have blood disorder like (leukemia, lymphoma, and thalassemia)
- Persons with impaired vision, speech and hearing (because either they may not be able to respond to questionnaire or conducting baseline dental training will be difficult).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Six Months Retention of Bonded Amalgam Sealants Versus Resin-based Sealants: A Randomized Controlled Trial
Dental caries, is one of the major public health problem in Pakistan. Dental sealants are known cost effective preventive measure of dental caries as compared to other preventive measures. Resin based sealants, is a proven treatment of pits and fissure sealants but retention is still problem. This trial will assess the use of amalgam sealants as an effective and retentive preventive measure in preventing dental caries in children as compared to the standard resin-based sealants. The findings of this randomized controlled trial will be used to raise awareness among the health care professionals, help them to choose amalgam sealants as an effective caries prevention method thereby reducing the burden of cost as amalgam is cheaper material compared to resin-based sealants.
The research question Is there any difference in the six months retention of bonded amalgam sealants compared to resin-based sealants among 12 to 16 years old children in Karachi
Read the detailed description
Objective:
To compare the six month retention of bonded amalgam sealants with that of resin-based sealants among 12 to 16 year old children in Karachi
Methods:
The study design will be parallel group, equivalence randomized controlled trial. Aim is to determine the equality of the Amalgam sealants retention compared to resin based sealants retention.
Outcome:
The primary outcome will be Retention, divided into Complete Retention, Partial Retention and Dislodgement of the sealant material.
- Conditions
- Incipient Enamel Caries, Fissure, Dental
- Being tested
- Amalgam sealant, Resin based sealant
- Medical subject headings
- Dental Fissures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amalgam sealantProcedure or surgery
Amalgam sealant placed on incipient enamel caries and deep enamel fissures.
Resin based sealantProcedure or surgery
Resin based sealant placed on incipient enamel caries and deep enamel fissures.
| Study group | Role | What they receive |
|---|---|---|
| Amalgam sealant | Experimental | Amalgam sealant placed on incipient enamel caries and deep enamel fissures. Receives: Procedure: Amalgam sealant |
| Resin based sealant | Active comparator | Resin based sealant placed on incipient enamel caries and deep enamel fissures. Receives: Procedure: Resin based sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of sealant
- Complete retention, if the all the occlusal fissures were covered by the sealant.
- Partial retention, if some of occlusal fissures of a tooth showed loss of sealant.
- Complete failure, if sealant was missing from all the occlusal fissure of the tooth.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 Feb 2017
- Primary completion1 Aug 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incipient Enamel CariesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design will be parallel group, equivalence randomized controlled trial. Aim is to determine the equality of the Amalgam sealants retention compared to resin based sealants retention.
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farhan Raza Khan, Aga Khan University
- Investigators
- Samreen L Khowaja, MSc, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130725
- Sponsor's protocol ID
- 4445-CHS-ERC-16
- Status last verified
- Jun 2018
- First submitted
- 22 Apr 2017
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan FR, Liaquat S, Rafique G, Azam SI, Hasan A. Bonded amalgam as a fissure sealant in low-income setting: A randomised controlled trial. J Pak Med Assoc. 2022 Feb;72(Suppl 1)(2):S3-S9. doi: 10.47391/JPMA.AKU-02.
PubMed 35202361
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Six Months Retention of Bonded Amalgam Sealants Versus Resin-based Sealants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03130725
- Acronym / sponsor ID
- 4445-CHS-ERC-16
- Conditions
- Incipient Enamel Caries, Fissure, Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 26 Apr 2017 (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.
Dental caries, is one of the major public health problem in Pakistan. Dental sealants are known cost effective preventive measure of dental caries as compared to other preventive measures. Resin based sealants, is a proven treatment of pits and fissure sealants but retention is still problem. This trial will assess the use of amalgam sealants as an effective and retentive preventive measure in preventing dental caries in children as compared to the standard resin-based sealants. The findings of this randomized controlled trial will be used to raise awareness among the health care professionals, help them to choose amalgam sealants as an effective caries prevention method thereby reducing the burden of cost as amalgam is cheaper material compared to resin-based sealants.
The research question Is there any difference in the six months retention of bonded amalgam sealants compared to resin-based sealants among 12 to 16 years old children in Karachi
Detailed description
Objective:
To compare the six month retention of bonded amalgam sealants with that of resin-based sealants among 12 to 16 year old children in Karachi
Methods:
The study design will be parallel group, equivalence randomized controlled trial. Aim is to determine the equality of the Amalgam sealants retention compared to resin based sealants retention.
Outcome:
The primary outcome will be Retention, divided into Complete Retention, Partial Retention and Dislodgement of the sealant material.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design will be parallel group, equivalence randomized controlled trial. Aim is to determine the equality of the Amalgam sealants retention compared to resin based sealants retention.
| Arm | Type | Receives |
|---|---|---|
| Amalgam sealant | Experimental | Procedure: Amalgam sealantAmalgam sealant placed on incipient enamel caries and deep enamel fissures. |
| Resin based sealant | Active comparator | Procedure: Resin based sealantResin based sealant placed on incipient enamel caries and deep enamel fissures. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children of aged 12 to 16 years (male and female) who will visit to the study site and fulfilled the eligibility criteria
- Teeth should be caries free at the time of sealants placement. As Dental sealant is a preventive treatment it is placed in a caries free surface. Incipient carious lesions will also be included.
- Teeth should be completely erupted, as incomplete eruption of teeth is highly correlates to the partial retention of sealants.
- Children who will give assent to participate in a study and their parents will give consent.
Key exclusion criteria (3 listed)
- Special needs children (because they need special attention of parents)
- Children who have blood disorder like (leukemia, lymphoma, and thalassemia)
- Persons with impaired vision, speech and hearing (because either they may not be able to respond to questionnaire or conducting baseline dental training will be difficult).
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 |
|---|---|---|
| Amalgam sealantAmalgam sealant placed on incipient enamel caries and deep enamel fissures. | Procedure or surgery | Amalgam sealant |
| Resin based sealantResin based sealant placed on incipient enamel caries and deep enamel fissures. | Procedure or surgery | Resin based sealant |
Primary outcome
Retention of sealant
Time frame: Six months
1. Complete retention, if the all the occlusal fissures were covered by the sealant. 2. Partial retention, if some of occlusal fissures of a tooth showed loss of sealant. 3. Complete failure, if sealant was missing from all the occlusal fissure of the tooth.
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 28 Jun 2018.
- Derived from this study: PubMed 35202361Khan FR, Liaquat S, Rafique G, Azam SI, Hasan A. Bonded amalgam as a fissure sealant in low-income setting: A randomised controlled trial. J Pak Med Assoc. 2022 Feb;72(Suppl 1)(2):S3-S9. doi: 10.47391/JPMA.AKU-02.
- Individual participant dataSharing planned: No
Related trials for Incipient Enamel Caries
Active, not recruiting
A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
Bracket Bonding, Orthodontic Treatment
Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Recruiting
EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH.
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Not yet recruiting
S-PRG Filler for Preventing White Spot Lesions During Orthodontic Treatment
White Spot Lesion of Tooth, Orthodontic Treatment
Recruiting
Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
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.
Samreen L Khowaja, MSc principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amalgam sealant and Resin based sealant in people with Incipient Enamel Caries and Fissure, Dental, run by Aga Khan University at 1 site in Pakistan.
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 4 inclusion and 3 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 28 Jun 2018. 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 Pakistan. 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.
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?
Retention of sealant (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03130725, which also lists 1 linked publication.
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 28 Jun 2018.