Treatment of permanent front teeth affected by hypomineralisation (white and yellow spots)
| ISRCTN | ISRCTN88218639 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88218639 |
| Secondary identifying numbers | 2654 |
- Submission date
- 17/02/2022
- Registration date
- 04/05/2022
- Last edited
- 04/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Hypomineralisation is a condition that affects the outer layer (enamel) of the teeth and can cause creamy/white/yellow/brown spots, enamel breakdown and tooth hypersensitivity. Hypersensitivity impairs tooth brushing and increases the risk of tooth decay. Resin infiltration treatment can improve the appearance of the teeth. This study aims to evaluate the effectiveness of resin infiltration in permanent incisors (front teeth) with yellow and white spots that are affected by hypomineralization.
Who can participate?
Children aged 6 to 16 years who have permanent incisors affected by hypomineralization with white and yellow spots
What does the study involve?
Chosen teeth are randomly allocated into two groups for one or multiple cycles of resin infiltration treatment. All teeth are assessed immediately and at 3 months after treatment.
What are the possible benefits and risks of participating?
There are no known risks to participants as any failed treatment will be redone using another method.
Where is the study run from?
Tishreen University (Syria)
When is the study starting and how long is it expected to run for?
January 2022 to July 2022
Who is funding the study?
Tishreen University (Syria)
Who is the main contact?
1. Dr Nabih Raslan, raslan.nabih@tishren.edu.sy
2. Mr Shams Alghawe, shams123490@gmail.com
Contact information
Scientific
Faculty of Dentistry
Lattakia
00963
Syria
| Phone | +963 (0)999673950 |
|---|---|
| shams.khaled.alghawe@tishreen.edu.sy |
Study information
| Study design | Interventional double-blind two-arm randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Management of permanent incisor affected by hypomineralisation using resin infiltration |
| Study hypothesis | Using icon etch (hcl) several times can improve cosmetic appearance more than using it once |
| Ethics approval(s) | Approved 21/05/2019, institutional review board of Tishreen University (Latakia, PO Box 2230, Syria; Tel: not available; dean.dentist@tishreen.edu.sy), ref: 2654 |
| Condition | Molar incisor hypomineralisation |
| Intervention | Participants are randomly allocated to either group A and group B using a random table. Group A is treated with Icon Etch for several cycles until a positive ethanol test is reached, not to exceed 3 cycles, whereas group B is treated with Icon Etch once. Participants are asked to attend a follow-up examination with clinical evaluation at 3 months post-treatment. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Full or partial positive spot coverage measured using a coverage scale immediately after treatment 2. Parent's satisfaction measured using a Likert scale immediately after treatment |
| Secondary outcome measures | Lesion color measured using the easyshade Compact device before and immediately after treatment and after 3 months |
| Overall study start date | 20/01/2022 |
| Overall study end date | 01/07/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 30 |
| Participant inclusion criteria | 1. Children who have permanent incisor with opacities 2. Aged 6 to 16 years |
| Participant exclusion criteria | 1. Children with signs of fluorosis, tetracycline staining, amelogenesis imperfecta, or generalized enamel hypoplasia 2. Undergoing orthodontic treatment 3. Opacities confined to the incisors only 4. Absence of parental consent to participate |
| Recruitment start date | 20/02/2022 |
| Recruitment end date | 20/05/2022 |
Locations
Countries of recruitment
- Syria
Study participating centre
Latakia
00963
Syria
Sponsor information
University/education
Faculty of Dentistry
Lattakia
00963
Syria
| Phone | +963 (0)968604778 |
|---|---|
| massamkhaddam@tishreen.edu.sy | |
| Website | http://en.tishreen.edu.sy/ |
"ROR" |
https://ror.org/04nqts970 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Nabih Raslan (raslan.nabih@tishreen.edu.sy), from 3 months after publication up to 3 years. Data will be available for researchers who provide a methodological sound proposal. |
Editorial Notes
29/04/2022: Trial's existence confirmed by Tishreen University.
