Caries PreventionNCT04579536
Effectiveness of Using (Vanish XT) in Prevention of Occlusal Caries: a RCT
A study testing Light curable resin modified glass ionomer varnish and Vanish White Varnish in people with Caries Prevention, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Despite the continuous effort to prevent and treat dental caries, it continues to be one of the most common chronic diseases in both children and adults. Prevention and minimally intervention treatment by early detection of the lesion are becoming the new philosophy in managing dental caries. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries Prevention
- What is being tested?
- Light curable resin modified glass ionomer varnish and Vanish White Varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Feb 2019to Jul 2021
- 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children having no history of any systemic condition.
- Children must have all four first permanent molar.
- Children must have at least one pair of contralateral newly erupted first permanent molars free from caries.
- Teeth with deep pits and fissures (at high risk for caries).
- These molars should be free of caries, restorations, sealants, fracture, hypoplasia, or cracks.
- High caries risk children.
Who cannot join
- Children whom their parents refused to sign the consent form.
- Children older than 9 years old.
- Medically compromised children.
- Children having discolored grooves, restored, caries, or hypoplastic first permanent molars.
- Children having proximal caries in first permanent molars.
- Children whose antagonist teeth were extracted or not erupted.
- Children with a known acrylate allergy.
- Uncooperative children.
Trial locations and contacts
1 site in 1 country.
Najlaa M Alamoudi, BDS,MSc,DSc contact
Saudi Arabia1 site, 1 recruiting
- Recruiting
King abulaziz University, Dental University Hospital
Jeddah, P.O Box 80209, 21589
Alaa M Baik, BDS,MSc, 00966126402000 ext. 23580, ambaik@kau.edu.sa
Alaa M Baik, BDS,MSc
About this study
Official title: Effectiveness of Using a Light Curable Resin Modified Glass Ionmer Cement Varnish (Vanish XT) in Prevention of Occlusal Caries: a Randomized Controlled Clinical Trial
Despite the continuous effort to prevent and treat dental caries, it continues to be one of the most common chronic diseases in both children and adults. Prevention and minimally intervention treatment by early detection of the lesion are becoming the new philosophy in managing dental caries. The prevalence of pit and fissure caries was found to be 90% of all dental caries in permanent molars. Moreover, the risk of caries development is higher soon after the tooth had erupted.
The purpose of the current study is; to evaluate the effectiveness of a resin-modified glass ionmer cement (Vanish XT) varnish in the prevention of occlusal caries and compare it to a fluoride varnish in newly erupted first permanent molars.
Read the detailed description
material and method: The sample will comprise of 84 bilateral pairs of newly erupted first permanent molars in children with age of 6-9 years.This sample will be randomly selected after patient's screening from pediatric dentistry clinics at King Abdul-Aziz University Dental Hospital, Jeddah, Saudi Arabia. Informed written consent will be obtained from the parents prior to sampling.
Healthy children with all four first permanent molar will be included in the study. Children must have at least one pair of contralateral newly erupted first permanent molars free from caries. Teeth with deep pits and fissures free of caries, restorations, sealants, fracture, hypoplasia, or cracks will be included in the study.
The children who met the inclusion criteria will be enrolled in the trial after a signed consent form is obtained. Pairs of maxillary or mandibular first molars will be included so that one side will be randomly assigned to study group and the contralateral side to control group.
Study group: This group will consist of 84 first permanent molars. These molars will be sealed using light curing resin-modified glass ionomer varnish (ClinproTM XT Vanish, 3M ESPE, Dental Products, St. Paul, MN, USA)
Control group: This group will consist of 84 first permanent molars. These molars will receive 5% Sodium Fluoride (NaF) with Tri-Calcium Phosphate topical varnish (Vanish White Varnish, 3M ESPE, Dental Products, St. Paul, MN, USA). These molars will serve as a control group.
The clinical examination will be assessing the caries lesions at baseline and 3,6, 12, and 18 months by the trained and calibrated dentists' according to ICDAS II criteria (International Caries Detection and Assessment System). Teeth with deep pits and fissures, which scored 0 will be included in this study.
In addition, once the clinical examination is done, bitewing radiographs will be taken for each child on the first visit to diagnose caries at the baseline.
A child structured questionnaire to be completed by interviewing the parents (adopted from WHO Oral Health Questionnaire for Children) concerning the dental history of the child and oral hygiene habits will be given at the baseline and at each recall visit.
- Conditions
- Caries Prevention
- Being tested
- Light curable resin modified glass ionomer varnish, Vanish White Varnish
- Keywords
- occlusal caries, Vanish XT varnish, Clinpro XT varnish, Light curable resin modified glass ionomer varnish, deep pits and fissures, newly erupted permanent first molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light curable resin modified glass ionomer varnishOther
Also called Vanish™ XT Extended Contact Varnish
Light curing resin-modified glass ionomer varnish (ClinproTM XT Vanish, 3M ESPE, Dental Products, St. Paul, MN, USA) will be used to seal 84 first permanent molars at baseline, 3, 6, 12 and 18 months.
Vanish White VarnishOther
5% Sodium Fluoride (NaF) with Tri-Calcium Phosphate topical varnish (Vanish White Varnish, 3M ESPE, Dental Products, St. Paul, MN, USA) will be used on 84 first permanent molars at baseline, 3, 6, 12 and 18 months.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | This is the study group; it will consist of 84 first permanent molars. These molars will be sealed using light curing resin-modified glass ionomer varnish (ClinproTM XT Vanish, 3M ESPE, Dental Products, St. Paul, MN, USA). reapplication will be done after 3,6, 12, and 18 months. Receives: Other: Light curable resin modified glass ionomer varnish |
| Control group | Other | This group will consist of 84 first permanent molars. These molars will receive 5% Sodium Fluoride (NaF) with Tri-Calcium Phosphate topical varnish (Vanish White Varnish, 3M ESPE, Dental Products, St. Paul, MN, USA). These molars will serve as a control group. reapplication will be done after 3,6, 12, and 18 months. Receives: Other: Vanish White Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
caries development
To evaluate development of occlusal caries in newly erupted permanent first molars using the ICDAS after treating the surface with light curable RMGI varnish and compare it with contra-lateral teeth which received white varnish.
Measured: 3 months
caries development
To evaluate development of occlusal caries in newly erupted permanent first molars using the ICDAS after treating the surface with light curable RMGI varnish and compare it with contra-lateral teeth which received white varnish.
Measured: 6 months
caries development
To evaluate development of occlusal caries in newly erupted permanent first molars using the ICDAS after treating the surface with light curable RMGI varnish and compare it with contra-lateral teeth which received white varnish.
Measured: 12 months
caries development
To evaluate development of occlusal caries in newly erupted permanent first molars using the ICDAS after treating the surface with light curable RMGI varnish and compare it with contra-lateral teeth which received white varnish.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Feb 2019
- Primary completion1 Feb 2020
- Study completionJul 2021 (estimated)
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 Caries PreventionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design of the study is a split-mouth, randomized controlled clinical trial in which the teeth are randomly assigned to be either in the test group or the control group in a 1:1 ratio. The control group: will be treated with 5% sodium fluoride (NaF) white varnish, oral hygiene instruction, and dietary counseling. The test group: will be treated with light curable resin modified glass ionomer (RMGI) varnish.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa M. Baik, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579536
- Sponsor's protocol ID
- Alaa Baik
- Status last verified
- Oct 2020
- First submitted
- 6 Oct 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baik A, Alamoudi N, Felemban O, El-Housseiny A, Almabadi E, Baik K, Altuwirqi A, Masoud I. Prevention of occlusal caries using VanishTM XT: an 18-month follow-up randomized clinical trial. BMC Oral Health. 2024 Nov 1;24(1):1328. doi: 10.1186/s12903-024-05095-8.
PubMed 39487418
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Using a Light Curable Resin Modified Glass Ionmer Cement Varnish (Vanish XT) in Prevention of Occlusal Caries: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04579536
- Acronym / sponsor ID
- Alaa Baik
- Conditions
- Caries Prevention
- Keywords
- occlusal caries, Vanish XT varnish, Clinpro XT varnish, Light curable resin modified glass ionomer varnish, deep pits and fissures, newly erupted permanent first molars
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- Jul 2021 (estimated)
- First posted
- 8 Oct 2020 (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.
Despite the continuous effort to prevent and treat dental caries, it continues to be one of the most common chronic diseases in both children and adults. Prevention and minimally intervention treatment by early detection of the lesion are becoming the new philosophy in managing dental caries. The prevalence of pit and fissure caries was found to be 90% of all dental caries in permanent molars. Moreover, the risk of caries development is higher soon after the tooth had erupted.
The purpose of the current study is; to evaluate the effectiveness of a resin-modified glass ionmer cement (Vanish XT) varnish in the prevention of occlusal caries and compare it to a fluoride varnish in newly erupted first permanent molars.
Detailed description
material and method: The sample will comprise of 84 bilateral pairs of newly erupted first permanent molars in children with age of 6-9 years.This sample will be randomly selected after patient's screening from pediatric dentistry clinics at King Abdul-Aziz University Dental Hospital, Jeddah, Saudi Arabia. Informed written consent will be obtained from the parents prior to sampling.
Healthy children with all four first permanent molar will be included in the study. Children must have at least one pair of contralateral newly erupted first permanent molars free from caries. Teeth with deep pits and fissures free of caries, restorations, sealants, fracture, hypoplasia, or cracks will be included in the study.
The children who met the inclusion criteria will be enrolled in the trial after a signed consent form is obtained. Pairs of maxillary or mandibular first molars will be included so that one side will be randomly assigned to study group and the contralateral side to control group.
Study group: This group will consist of 84 first permanent molars. These molars will be sealed using light curing resin-modified glass ionomer varnish (ClinproTM XT Vanish, 3M ESPE, Dental Products, St. Paul, MN, USA)
Control group: This group will consist of 84 first permanent molars. These molars will receive 5% Sodium Fluoride (NaF) with Tri-Calcium Phosphate topical varnish (Vanish White Varnish, 3M ESPE, Dental Products, St. Paul, MN, USA). These molars will serve as a control group.
The clinical examination will be assessing the caries lesions at baseline and 3,6, 12, and 18 months by the trained and calibrated dentists' according to ICDAS II criteria (International Caries Detection and Assessment System). Teeth with deep pits and fissures, which scored 0 will be included in this study.
In addition, once the clinical examination is done, bitewing radiographs will be taken for each child on the first visit to diagnose caries at the baseline.
A child structured questionnaire to be completed by interviewing the parents (adopted from WHO Oral Health Questionnaire for Children) concerning the dental history of the child and oral hygiene habits will be given at the baseline and at each recall visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The design of the study is a split-mouth, randomized controlled clinical trial in which the teeth are randomly assigned to be either in the test group or the control group in a 1:1 ratio. The control group: will be treated with 5% sodium fluoride (NaF) white varnish, oral hygiene instruction, and dietary counseling. The test group: will be treated with light curable resin modified glass ionomer (RMGI) varnish.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Light curable resin modified glass ionomer varnishThis is the study group; it will consist of 84 first permanent molars. These molars will be sealed using light curing resin-modified glass ionomer varnish (ClinproTM XT Vanish, 3M ESPE, Dental Products, St. Paul, MN, USA). reapplication will be done after 3,6, 12, and 18 months. |
| Control group | Other | Other: Vanish White VarnishThis group will consist of 84 first permanent molars. These molars will receive 5% Sodium Fluoride (NaF) with Tri-Calcium Phosphate topical varnish (Vanish White Varnish, 3M ESPE, Dental Products, St. Paul, MN, USA). These molars will serve as a control group. reapplication will be done after 3,6, 12, and 18 months. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy children having no history of any systemic condition.
- Children must have all four first permanent molar.
- Children must have at least one pair of contralateral newly erupted first permanent molars free from caries.
- Teeth with deep pits and fissures (at high risk for caries).
- These molars should be free of caries, restorations, sealants, fracture, hypoplasia, or cracks.
Key exclusion criteria (8 listed)
- Children whom their parents refused to sign the consent form.
- Children older than 9 years old.
- Medically compromised children.
- Children having discolored grooves, restored, caries, or hypoplastic first permanent molars.
- Children having proximal caries in first permanent molars.
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 |
|---|---|---|
| Light curable resin modified glass ionomer varnishAlso: Vanish™ XT Extended Contact VarnishLight curing resin-modified glass ionomer varnish (ClinproTM XT Vanish, 3M ESPE, Dental Products, St. Paul, MN, USA) will be used to seal 84 first permanent molars at baseline, 3, 6, 12 and 18 months. | Other | Study group |
| Vanish White Varnish5% Sodium Fluoride (NaF) with Tri-Calcium Phosphate topical varnish (Vanish White Varnish, 3M ESPE, Dental Products, St. Paul, MN, USA) will be used on 84 first permanent molars at baseline, 3, 6, 12 and 18 months. | Other | Control group |
Primary outcome
caries development
Time frame: 3 months
To evaluate development of occlusal caries in newly erupted permanent first molars using the ICDAS after treating the surface with light curable RMGI varnish and compare it with contra-lateral teeth which received white varnish.
caries development
Time frame: 6 months
To evaluate development of occlusal caries in newly erupted permanent first molars using the ICDAS after treating the surface with light curable RMGI varnish and compare it with contra-lateral teeth which received white varnish.
caries development
Time frame: 12 months
To evaluate development of occlusal caries in newly erupted permanent first molars using the ICDAS after treating the surface with light curable RMGI varnish and compare it with contra-lateral teeth which received white varnish.
caries development
Time frame: 18 months
To evaluate development of occlusal caries in newly erupted permanent first molars using the ICDAS after treating the surface with light curable RMGI varnish and compare it with contra-lateral teeth which received white varnish.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 39487418Baik A, Alamoudi N, Felemban O, El-Housseiny A, Almabadi E, Baik K, Altuwirqi A, Masoud I. Prevention of occlusal caries using VanishTM XT: an 18-month follow-up randomized clinical trial. BMC Oral Health. 2024 Nov 1;24(1):1328. doi: 10.1186/s12903-024-05095-8.
- Individual participant dataSharing planned: No
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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.
Najlaa M Alamoudi, BDS,MSc,DSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light curable resin modified glass ionomer varnish and Vanish White Varnish in people with Caries Prevention, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. 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 Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa M Baik, BDS,MSc (00966 2 640-1000 ext. 23580, ambaik@kau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caries development (time frame: 3 months). The study lists 4 primary outcomes in all. 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 NCT04579536, 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 8 Oct 2020.