White Spot LesionsPhase 2NCT02912741
One Year Clinical Evaluation of White Spot Lesions Treated With Newly Introduced Resin Modified Glass Ionomer in Comparison to Resin Infiltration in Anterior Teeth Split Mouth Technique
A Phase 2 study testing Vanish xt Extended Contact Varnish and resin infiltration in people with White Spot Lesions, run by Cairo University.
Trial summary
The aim of this study is to evaluate the addition of new technology of resin modified glass-ionomer in comparison to resin infiltration in treating post-orthodontic white spot lesions; both applies into the same patient's mouth; to reveal which material will have more clinical satisfactory performance inside the oral… Read more about this study
- Who is it for?
- Ages Up to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesions
- What is being tested?
- Vanish xt Extended Contact Varnish and resin infiltration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to May 2018
- Phase
- Phase 2
- 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 Up to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Post-Orthodontic patients included in this clinical trial toll age of 35 years.
- Patients with good general health.
- Patients who will agree to the consent and will commit to follow-up period.
- Fully erupted anterior teeth with no cavitated lesions.
- At least one spot lesion on each side in the same jaw
Who cannot join
- Patients with any systemic disease that may affect normal healing.
- Patient with bad oral hygiene.
- Tetracycline or fluorsis staining.
- Patients who could/would not participate in all times of follow-up.
- Untreated periodontal disease was not allowed.
- Active caries or defective Restorations in 6 anterior teeth.
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- Bleaching history
- Patients participating in more than 1 dental study.
- Patient received fluoride varnish during orthodontic treatment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Double Blinded Randomized Clinical Trial for Evaluation of Resin Modified Glass Ionomer Cement Versus Resin Infiltration in Treating White Spot Lesions
The aim of this study is to evaluate the addition of new technology of resin modified glass-ionomer in comparison to resin infiltration in treating post-orthodontic white spot lesions; both applies into the same patient's mouth; to reveal which material will have more clinical satisfactory performance inside the oral cavity and to overcome the high expensive cost in treating such clinical cases
Read the detailed description
Roles and responsibilities:
- Shaimaa Mohammed (SH.M.): Operator and author.Specialist in Air-Force Specialized Hospital.
- Mohamed Riad (M.R.): Main supervisor, data monitoring and auditing, Professor, Conservative Dentistry Department,Cairo University.
- Asma Harhash(A.H.):Co-supervisor, outcome assessor and data collection, Associate Professor, Russian University.
- Omnia Magdy Moustafa (O.M.): Baseline data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants consents: Assistant lecturer, Conservative Dentistry Department , Faculty of Oral and Dental Medicine Cairo University.
- Ghada Ahmed (G.A.): Data entry and auditing; Assistant lecturer, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Russian University.
Intervention:
A- Preoperative clinical assessment:
- Explain patient need toward aesthetic needs
- Digital photos for white spot lesions
- Recording number of white spot lesions and site. (SH.M.) will apply both materials at the same patient mouth (Split mouth technique) according to the manufacturer's instructions.
- Intervention: resin modified glass ionomer cement varnish: Vanish™ xt Extended Contact Varnish (3M ESPE Dental)
- Comparator: resin infiltration (Dental Milestones Guaranteed, Germany). (A.H) and (SH.M) will assess the outcome measures through the follow up time: immediately after,1 day, 1 week,1 month,3 months, 6 months, 12 months
- Conditions
- White Spot Lesions
- Being tested
- Vanish xt Extended Contact Varnish, resin infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vanish xt Extended Contact VarnishDrug
Also called Clinpro xt
resin modified glass- ionomer cement varnish applied as a thin layer coating and cured
resin infiltrationDrug
Also called ICON
low viscous light cure resin applied in layers and cured
| Study group | Role | What they receive |
|---|---|---|
| Vanish xt Extended Contact Varnish | Experimental | Vanish xt Extended Contact Varnish is a resin modified glass ionomer cement and fluoride varnish used to treat white spot lesions to be more resistant to early caries progression. Receives: Drug: Vanish xt Extended Contact Varnish |
| Resin infiltration | Active comparator | Resin infiltration is a low viscous resin infiltrates into small pores of white spot lesions to block entrance of bacteria into dentinal tubules of the tooth and more resistant to early caries progression. Receives: Drug: resin infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient satisfaction
using visual analogue scale ruler (0-100 mm) 0 refer to not satisfied at all,100 refer to total satisfied
Measured: immediately, 1 day, 1week,1 month,3 month,6 month and1 year
Secondary outcomes (1)
Change in color change
using vita easy shade device
Measured: immediately, 1 day, 1week,1 month,3 month,6 month and1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohamed Mostafa Rohym, Cairo University
- Investigators
- Ahmed Elkhadem, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912741
- Sponsor's protocol ID
- CEBD-CU-2016-09-209
- Status last verified
- Sep 2016
- First submitted
- 20 Sep 2016
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded Randomized Clinical Trial for Evaluation of Resin Modified Glass Ionomer Cement Versus Resin Infiltration in Treating White Spot Lesions
- ClinicalTrials.gov ID
- NCT02912741
- Acronym / sponsor ID
- CEBD-CU-2016-09-209
- Conditions
- White Spot Lesions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 23 Sep 2016 (estimated)
- 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.
The aim of this study is to evaluate the addition of new technology of resin modified glass-ionomer in comparison to resin infiltration in treating post-orthodontic white spot lesions; both applies into the same patient's mouth; to reveal which material will have more clinical satisfactory performance inside the oral cavity and to overcome the high expensive cost in treating such clinical cases
Detailed description
Roles and responsibilities:
- Shaimaa Mohammed (SH.M.): Operator and author.Specialist in Air-Force Specialized Hospital.
- Mohamed Riad (M.R.): Main supervisor, data monitoring and auditing, Professor, Conservative Dentistry Department,Cairo University.
- Asma Harhash(A.H.):Co-supervisor, outcome assessor and data collection, Associate Professor, Russian University.
- Omnia Magdy Moustafa (O.M.): Baseline data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants consents: Assistant lecturer, Conservative Dentistry Department , Faculty of Oral and Dental Medicine Cairo University.
- Ghada Ahmed (G.A.): Data entry and auditing; Assistant lecturer, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Russian University.
Intervention:
A- Preoperative clinical assessment:
- Explain patient need toward aesthetic needs
- Digital photos for white spot lesions
- Recording number of white spot lesions and site. (SH.M.) will apply both materials at the same patient mouth (Split mouth technique) according to the manufacturer's instructions.
- Intervention: resin modified glass ionomer cement varnish: Vanish™ xt Extended Contact Varnish (3M ESPE Dental)
- Comparator: resin infiltration (Dental Milestones Guaranteed, Germany). (A.H) and (SH.M) will assess the outcome measures through the follow up time: immediately after,1 day, 1 week,1 month,3 months, 6 months, 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vanish xt Extended Contact Varnish | Experimental | Drug: Vanish xt Extended Contact VarnishVanish xt Extended Contact Varnish is a resin modified glass ionomer cement and fluoride varnish used to treat white spot lesions to be more resistant to early caries progression. |
| Resin infiltration | Active comparator | Drug: resin infiltrationResin infiltration is a low viscous resin infiltrates into small pores of white spot lesions to block entrance of bacteria into dentinal tubules of the tooth and more resistant to early caries progression. |
Who may qualify
- Ages
- Up to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Post-Orthodontic patients included in this clinical trial toll age of 35 years.
- Patients with good general health.
- Patients who will agree to the consent and will commit to follow-up period.
- Fully erupted anterior teeth with no cavitated lesions.
- At least one spot lesion on each side in the same jaw
Key exclusion criteria (9 listed)
- Patients with any systemic disease that may affect normal healing.
- Patient with bad oral hygiene.
- Tetracycline or fluorsis staining.
- Patients who could/would not participate in all times of follow-up.
- Untreated periodontal disease was not allowed.
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 |
|---|---|---|
| Vanish xt Extended Contact VarnishAlso: Clinpro xtresin modified glass- ionomer cement varnish applied as a thin layer coating and cured | Drug | Vanish xt Extended Contact Varnish |
| resin infiltrationAlso: ICONlow viscous light cure resin applied in layers and cured | Drug | Resin infiltration |
Primary outcome
Change in Patient satisfaction
Time frame: immediately, 1 day, 1week,1 month,3 month,6 month and1 year
using visual analogue scale ruler (0-100 mm) 0 refer to not satisfied at all,100 refer to total satisfied
1 secondary outcome
Change in color change
Time frame: immediately, 1 day, 1week,1 month,3 month,6 month and1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Individual participant dataSharing planned: Undecided
Related trials for White Spot Lesions
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Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
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EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH.
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S-PRG Filler for Preventing White Spot Lesions During Orthodontic Treatment
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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.
Ahmed Elkhadem, PhD study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vanish xt Extended Contact Varnish and resin infiltration in people with White Spot Lesions, run by Cairo University.
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 5 inclusion and 9 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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shaimaa Mohammed Rohym, Master (01007374670, drshdentist@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient satisfaction (time frame: immediately, 1 day, 1week,1 month,3 month,6 month and1 year). 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 23 Sep 2016.