ClinicalTrials.gg
Status unknownNCT02913885Updated Sep 26, 2016

Effect of Curodont Repair on Color Change of White Spot Lesions

A Phase 2 interventional study of Curodont Repair and fluoride varnish in White Spot Lesion, sponsored by Cairo University. Status unknown. Open to participants aged 12 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-26.

Sponsored by Cairo University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
12 Years to 25 Years
Sex
All
01

Study 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 the detailed description

Roles and responsibilities:

  1. Aalaa Mohamed Nabil Amin Abdullatif (A.N.) Operator, data enterer and corresponding author; Assistant lecturer, Conservative Dentistry Department, ModernTechnology University, Egypt.
  2. Mohamed Riad (M.R) Main supervisor, data monitoring, auditing Professor, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  3. Rasha Haridy (R.H.) Co-supervisor, data entry and auditing; Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  4. Ahmed Refaat Mohamed (A.R.) Outcome assessors and data collection; Lecturers, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  5. Heba fathy (H.F) Outcome assessors and data collection; Assistant lecturer,, Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  6. 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.
  7. Eman Desouky (E.D.) Sample size calculation; Statistician, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  8. Evidence Based Dentistry Committee (CEBD) Help in reporting study protocol following SPIRIT guidelines; Faculty of Oral and Dental Medicine, Cairo University, Egypt.
  9. 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:

  1. 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

  2. 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).

02

Conditions studied

  • White Spot Lesion
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. No systemic disease.
  2. Has completed fixed orthodontic treatment, brackets debonded.
  3. Has at least two teeth with white spot lesion.
  4. Has received conventional periodontal therapy after orthodontic treatment.
  5. Between the ages of 12 and 25 years of age

Exclusion criteria

Exclusion Criteria:

  1. presence of enamel hypoplasia or dental fluorosis.
  2. presence of tetracycline pigmentation.
  3. periodontal pocketing of 3mm or greater.
  4. taking antibiotics.
  5. presence of carious cavities.
  6. allergy to fluoride gel / varnish being used in study.
  7. Subjects who had evidence of reduced salivary flow or significant tooth wear
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
64 participants (estimated)

Study arms

  • Active comparator
    Group 2

    curodont repair is a biomimetic regeneration scaffold for remineralization

    Drug: Curodont Repair · Drug: fluoride varnish

  • Experimental
    Group 1

    fluoride varnish inhibit progression of white spot lesion

    Drug: Curodont Repair · Drug: fluoride varnish

Interventions

  • DrugCurodont Repair

    composed of biomimetic regeneration scaffold self-assembling peptides (P11-4) used for remineralization

    Also known as: CURODONT™ REPAIR,Credentis, Switzerland

  • fluoride inhibit the progression of white spot lesion

    Also known as: 2.26% F, Duraphat, WoelmPharma GmbH, Germany

06

What researchers measure

Primary outcomes

  1. change in patient satisfaction

    using visual analogue scale from 0-100 (0= not satisfied , 100= totally satisfied)

    Time frame: before, after 3 and 6 months

Secondary outcomes

  1. change in color shade

    will use vita easy shade devise

    Time frame: before, after 3 and 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2017, a primary completion of Jul 2017 and a completion of Sep 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2016
First posted
Sep 26, 2016
Start
Jan 2017
Primary completionEst.
Jul 2017
CompletionEst.
Sep 2017
Last update
Sep 26, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02913885
Lead sponsor
Cairo University
Responsible party
Aalaa Mohamed Nabil (assistant lecturer, conservative Dentistry Department MTI university, Cairo University) — Principal investigator
First posted
Sep 26, 2016
Start date
Jan 2017
Primary completion
Jul 2017 (estimated)
Completion
Sep 2017 (estimated)
Last update
Sep 26, 2016

Study contacts

aalaa M. Nabil, Master
Contact
aalaanabil@gmail.com
01229709666
rasha haridy, phD
Contact
rh_haridy@hotmail.com
01004709947

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Sodium Fluoride

Start the discussion