White Spot LesionPhase 2NCT02913885
Effect of Curodont Repair on Color Change of White Spot Lesions
A Phase 2 study testing Curodont Repair and fluoride varnish in people with White Spot Lesion, run by Cairo University.
Trial summary
The aim of this study is to compare the effect of color change between remineralizing agent and guided enamel regeneration in treatment of white spot lesion after orthodontic treatments Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- Curodont Repair and fluoride varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Sep 2017
- 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 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- No systemic disease.
- Has completed fixed orthodontic treatment, brackets debonded.
- Has at least two teeth with white spot lesion.
- Has received conventional periodontal therapy after orthodontic treatment.
- Between the ages of 12 and 25 years of age
Who cannot join
- presence of enamel hypoplasia or dental fluorosis.
- presence of tetracycline pigmentation.
- periodontal pocketing of 3mm or greater.
- taking antibiotics.
- presence of carious cavities.
- allergy to fluoride gel / varnish being used in study.
- Subjects who had evidence of reduced salivary flow or significant tooth wear
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Using Biomimetic Remineralization Versus Fluoride Varnish In Management Of White Spot Lesion In Post Orthodontic Treated Patient: (Split Mouth Technique ) A Randomized Clinical Trial
The aim of this study is to compare the effect of color change between remineralizing agent and guided enamel regeneration in treatment of white spot lesion after orthodontic treatments
Read the detailed description
Roles and responsibilities:
- Aalaa Mohamed Nabil Amin Abdullatif (A.N.) Operator, data enterer and corresponding author; Assistant lecturer, Conservative Dentistry Department, ModernTechnology University, Egypt.
- Mohamed Riad (M.R) Main supervisor, data monitoring, auditing Professor, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Rasha Haridy (R.H.) Co-supervisor, data entry and auditing; Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Ahmed Refaat Mohamed (A.R.) Outcome assessors and data collection; Lecturers, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Heba fathy (H.F) Outcome assessors and data collection; Assistant lecturer,, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Ahmed Mamdouh Ahmed (A.M.) Base line data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants' consents; Resident, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Eman Desouky (E.D.) Sample size calculation; Statistician, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Evidence Based Dentistry Committee (CEBD) Help in reporting study protocol following SPIRIT guidelines; Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Research Ethics Committee (CREC) Protocol reviewer of the clinical trial in order to protect the right, safety, dignity and well-being of the participants; Faculty of Oral and Dental Medicine, Cairo University, Egypt.
1-Intervention: A.N. will treat the lesion with 2 % NaOCl for 20 sec, then rinsed and dried. A.N. will etch the lesion with 35 % Phosphoric acid for 20 sec to open up the pores to the subsurface lesion and sub¬sequently rinsed with water for 20 sec and air-dried. A.N. will apply (CURODONT™ REPAIR,Credentis, Switzerland) for two to three minutes. A.N. will advise the patients to rinse the quadrant containing the treated teeth using chlorhexidine mouthwash (Corsodyl, Herrenberg, Germany) until Day 4 and avoid teeth brushing. At D4, A.N. will ask the patients to use a soft tooth brush and tooth paste until Day 8. At this point they will be reverted to their normal oral hygiene procedures.
2-Comparator: A.N. will apply (2.26% F, Duraphat, WoelmPharma,Gesellschaft mit beschränkter Haftung, Germany). onto the tooth surfaces with White Spot Lesions using a brush, with the applicator dabbed repeatedly onto the tooth surface without contacting soft tissues. After a few minutes, a thin and clear layer is formed. A.N. will advise the patients not to brush their teeth or chew food for at least 4 hrs after treatment; during this time, soft food and liquid might be consumed.
3-Outcomes:
- Patient satisfaction: H.F.\& A.R will measure patient satisfaction using Visual Analogue Scale scores. The mean and standard deviation for the VAS scores of the patients recorded preoperatively, at the time of materials application, 3,6 months review for aesthetics
- Color change assessment:
H.F.\& A.R will perform visual color evaluation using the Vita Easyshade Compact (Vita Zahnfabrik, Bad Sa¨ckingen,Germany).
The shade tab may now be measured by holding the probe tip at 90° to surface at the middle 1/3 of the tab, pressing the measurement button on the Hand Piece, and waiting until the Easyshade "beeps" to indicate successful completion of the measurement H.F.\& A.R will hold the probe tip 90ᴼ to the WSL on tooth surface and pressing the measurement bottom on the hand piece and waiting until the easyshade beeps to indicate successful completion of the measurement , Three images will be captured for each tooth at each time point, and the average values for L* (lightness, achromatic color coordinate), a* (green/red coordinate), b* (blue/yellow coordinate), and the resultant color difference (ϪE*) over the three measurements will be calculated H.F.\& A.R will perform the visual color assessments at baseline (T0) to record the color characteristics of the WSLs immediately after treatment, (T1) to record the color characteristics of the WSL after 3 months, (T2) to record the color characteristics of the WSL after 6 months. The instrumental color measurements will be performed using the Commission International de I'Eclariage (CIE) L*a*b* color notation system (CIELAB).
- Conditions
- White Spot Lesion
- Being tested
- Curodont Repair, fluoride varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curodont RepairDrug
Also called CURODONT™ REPAIR,Credentis, Switzerland
composed of biomimetic regeneration scaffold self-assembling peptides (P11-4) used for remineralization
fluoride varnishDrug
Also called 2.26% F, Duraphat, WoelmPharma GmbH, Germany
fluoride inhibit the progression of white spot lesion
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Active comparator | curodont repair is a biomimetic regeneration scaffold for remineralization Receives: Drug: Curodont Repair; Drug: fluoride varnish |
| Group 1 | Experimental | fluoride varnish inhibit progression of white spot lesion Receives: Drug: Curodont Repair; Drug: fluoride varnish |
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 from 0-100 (0= not satisfied , 100= totally satisfied)
Measured: before, after 3 and 6 months
Secondary outcomes (1)
change in color shade
will use vita easy shade devise
Measured: before, after 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startJan 2017
- Primary completionJul 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionStudies 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aalaa Mohamed Nabil, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913885
- Sponsor's protocol ID
- CEBD-CU-2016-09-199
- Status last verified
- Sep 2016
- First submitted
- 21 Sep 2016
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Using Biomimetic Remineralization Versus Fluoride Varnish In Management Of White Spot Lesion In Post Orthodontic Treated Patient: (Split Mouth Technique ) A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02913885
- Acronym / sponsor ID
- CEBD-CU-2016-09-199
- Conditions
- White Spot Lesion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 26 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 compare the effect of color change between remineralizing agent and guided enamel regeneration in treatment of white spot lesion after orthodontic treatments
Detailed description
Roles and responsibilities:
- Aalaa Mohamed Nabil Amin Abdullatif (A.N.) Operator, data enterer and corresponding author; Assistant lecturer, Conservative Dentistry Department, ModernTechnology University, Egypt.
- Mohamed Riad (M.R) Main supervisor, data monitoring, auditing Professor, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Rasha Haridy (R.H.) Co-supervisor, data entry and auditing; Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Ahmed Refaat Mohamed (A.R.) Outcome assessors and data collection; Lecturers, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Heba fathy (H.F) Outcome assessors and data collection; Assistant lecturer,, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Ahmed Mamdouh Ahmed (A.M.) Base line data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants' consents; Resident, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Eman Desouky (E.D.) Sample size calculation; Statistician, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Evidence Based Dentistry Committee (CEBD) Help in reporting study protocol following SPIRIT guidelines; Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- Research Ethics Committee (CREC) Protocol reviewer of the clinical trial in order to protect the right, safety, dignity and well-being of the participants; Faculty of Oral and Dental Medicine, Cairo University, Egypt.
1-Intervention: A.N. will treat the lesion with 2 % NaOCl for 20 sec, then rinsed and dried. A.N. will etch the lesion with 35 % Phosphoric acid for 20 sec to open up the pores to the subsurface lesion and sub¬sequently rinsed with water for 20 sec and air-dried. A.N. will apply (CURODONT™ REPAIR,Credentis, Switzerland) for two to three minutes. A.N. will advise the patients to rinse the quadrant containing the treated teeth using chlorhexidine mouthwash (Corsodyl, Herrenberg, Germany) until Day 4 and avoid teeth brushing. At D4, A.N. will ask the patients to use a soft tooth brush and tooth paste until Day 8. At this point they will be reverted to their normal oral hygiene procedures.
2-Comparator: A.N. will apply (2.26% F, Duraphat, WoelmPharma,Gesellschaft mit beschränkter Haftung, Germany). onto the tooth surfaces with White Spot Lesions using a brush, with the applicator dabbed repeatedly onto the tooth surface without contacting soft tissues. After a few minutes, a thin and clear layer is formed. A.N. will advise the patients not to brush their teeth or chew food for at least 4 hrs after treatment; during this time, soft food and liquid might be consumed.
3-Outcomes:
- Patient satisfaction: H.F.\& A.R will measure patient satisfaction using Visual Analogue Scale scores. The mean and standard deviation for the VAS scores of the patients recorded preoperatively, at the time of materials application, 3,6 months review for aesthetics
- Color change assessment:
H.F.\& A.R will perform visual color evaluation using the Vita Easyshade Compact (Vita Zahnfabrik, Bad Sa¨ckingen,Germany).
The shade tab may now be measured by holding the probe tip at 90° to surface at the middle 1/3 of the tab, pressing the measurement button on the Hand Piece, and waiting until the Easyshade "beeps" to indicate successful completion of the measurement H.F.\& A.R will hold the probe tip 90ᴼ to the WSL on tooth surface and pressing the measurement bottom on the hand piece and waiting until the easyshade beeps to indicate successful completion of the measurement , Three images will be captured for each tooth at each time point, and the average values for L* (lightness, achromatic color coordinate), a* (green/red coordinate), b* (blue/yellow coordinate), and the resultant color difference (ϪE*) over the three measurements will be calculated H.F.\& A.R will perform the visual color assessments at baseline (T0) to record the color characteristics of the WSLs immediately after treatment, (T1) to record the color characteristics of the WSL after 3 months, (T2) to record the color characteristics of the WSL after 6 months. The instrumental color measurements will be performed using the Commission International de I'Eclariage (CIE) L*a*b* color notation system (CIELAB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Active comparator | Drug: Curodont Repair, Drug: fluoride varnishcurodont repair is a biomimetic regeneration scaffold for remineralization |
| Group 1 | Experimental | Drug: Curodont Repair, Drug: fluoride varnishfluoride varnish inhibit progression of white spot lesion |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- No systemic disease.
- Has completed fixed orthodontic treatment, brackets debonded.
- Has at least two teeth with white spot lesion.
- Has received conventional periodontal therapy after orthodontic treatment.
- Between the ages of 12 and 25 years of age
Key exclusion criteria (7 listed)
- presence of enamel hypoplasia or dental fluorosis.
- presence of tetracycline pigmentation.
- periodontal pocketing of 3mm or greater.
- taking antibiotics.
- presence of carious cavities.
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 |
|---|---|---|
| Curodont RepairAlso: CURODONT™ REPAIR,Credentis, Switzerlandcomposed of biomimetic regeneration scaffold self-assembling peptides (P11-4) used for remineralization | Drug | Group 1, Group 2 |
| fluoride varnishAlso: 2.26% F, Duraphat, WoelmPharma GmbH, Germanyfluoride inhibit the progression of white spot lesion | Drug | Group 1, Group 2 |
Primary outcome
change in patient satisfaction
Time frame: before, after 3 and 6 months
using visual analogue scale from 0-100 (0= not satisfied , 100= totally satisfied)
1 secondary outcome
change in color shade
Time frame: before, after 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Curodont Repair and fluoride varnish in people with White Spot Lesion, 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 7 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 26 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 aalaa M. Nabil, Master (01229709666, aalaanabil@gmail.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: before, after 3 and 6 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 26 Sep 2016.