Dental sealant quality, chair time, and patients' preference of three isolation techniques
| ISRCTN | ISRCTN10452417 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10452417 |
- Submission date
- 13/05/2021
- Registration date
- 14/05/2021
- Last edited
- 10/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
During dental work, it is common to isolate the tooth from the rest of the person's mouth, which allows the tooth to be repaired dry and with relatively less exposure to bacteria in the mouth. This randomized clinical trial aimed to evaluate the patient’s preference and chair time needed under three isolation techniques (Isolite system, rubber dam isolation, and cotton roll isolation.
Who can participate?
Children aged 6-15 years requiring four sealants on the first or second permanent molars attending the pediatric dental clinics at King Saud University in Saudi Arabia
What does the study involve?
Each participant received sealants on three random first or second permanent molars using three isolation techniques. The time required for sealant placement was recorded for each technique. Following sealant placement, an interview-based questionnaire was administered to the participants to evaluate their preference regarding the isolation techniques.
What are the possible benefits and risks of participating?
All participants will benefit from oral hygiene instructions, examination, prophylaxis and pit and fissure sealant placement. No risks.
Where is the study run from?
King Saud University (Saudi Arabia)
When is the study starting and how long is it expected to run for?
February 2018 to February 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Rahif Mattar, rahifmattar@hotmail.com
Contact information
Public
Department of Pediatric Dentistry and Orthodontics
College of Dentistry
King Saud University
Riyadh
11545
Saudi Arabia
 ORCID ID |
0000-0002-3102-2857 |
|---|---|
| Phone | +966-11 469-7835 |
| 437204377@student.ksu.edu.sa |
Study information
| Study design | Split-mouth randomized clinical trial single center |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Comparison of the quality of fissure sealant and the preference of pediatric dental patients with three different isolation techniques |
| Study objectives | 1. The Isolite system will have a higher patient preference when compared to Rubber Dam isolation and Cotton roll isolation 2. The chair time using Isolite system will have a shorter chair time than that using Rubber dam isolation and Cotton roll isolation 3. The quality of pit and fissure sealant using Isolite system will be higher than that using Rubber dam isolation and Cotton roll isolation |
| Ethics approval(s) | 1. Approved 20/11/2018, The Institutional Review Board (King Saud University, PO Box 7805, Riyadh, Saudi Arabia; +966-11 469-1531; rdeocampo@ksu.edu.sa ), ref: E-18- 3376 2. Approved 29/01/2020, The College of Dentistry Research Center (College of Dentistry, King Saud University, PO Box 7805, Riyadh, Saudi Arabia; +966-11 469-1532; irb.medksu@hotmail.com), ref: PR 0103 |
| Health condition(s) or problem(s) studied | Isolation techniques for dental treatment |
| Intervention | Forty-eight children aged 6 - 15 years participated according to inclusion/exclusion criteria. They were randomized by using simple block random allocation to ensure a balanced randomization for each isolation system using random numbers that were generated using a computer program (MedCalc). The sealed envelope technique was used. Each participant participant received three pit and fissure sealants on their permanent first or second molars using three different isolation techniques (Isolite system Rubber Dam isolation and Cotton roll isolation) according to randomization by a single operator. The time was measured by a stop watch, the quality of sealants were assessed by a blinded evaluator. Following sealant placement, an interview-based questionnaire was administered to the participants to evaluate their preference regarding the isolation techniques. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Isolite System by Zyris |
| Primary outcome measure | Measured at a single time point for each technique: 1. Sealants quality was evaluated according to Simonsen’s criteria 2. Sealant chair time was measured using a stopwatch 3. Patients' preference was measured according to a novel validated questionnaire |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 12/02/2018 |
| Completion date | 23/02/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 48 |
| Total final enrolment | 48 |
| Key inclusion criteria | 1. Normal healthy patient with ASA 1 according to the American Society of Anesthesiologists Classification 2. Children aged 6 - 15 years, willing to participate in the study 3. Legal guardian accepts the participation of the child in the study 4. Participant must require 4 pits and fissure sealants on all first or second permanent molars with an International Caries Detection and Assessment System (ICDAS) score of 0 - 2, and 5) Arabic or English speaker children |
| Key exclusion criteria | 1. Special Needs children 2. Conditions requiring emergency dental treatment (abscess, draining sinus, cellulitis) 3. Partially erupted permanent first or second molars 4. Enamel/Dentin anomalies 5. Uncooperative children, Frankl Behavior Rating Scale of 1 or 2 6. Children with a severe gagging reflex 7. Children allergic to latex 8. Children with recent dental radiographs taken but not available on the computer system |
| Date of first enrolment | 25/11/2018 |
| Date of final enrolment | 02/01/2020 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
College of Dentistry
Riyadh
11545
Saudi Arabia
Sponsor information
University/education
Department of Pediatric Dentistry and Orthodontics
College of Dentistry
Riyadh
11545
Saudi Arabia
| Phone | +966-11 469-1531 |
|---|---|
| rdeocampo@ksu.edu.sa | |
| Website | http://ksu.edu.sa/en/ |
"ROR" |
https://ror.org/02f81g417 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2021 |
|---|---|
| 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 (Rahif Mattar, e-mail: rahifmattar@hotmail.com, excel sheet, the data will become available upon request, written consent from participants was obtained, no ethical or legal restrictions). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 25/05/2021 | 15/06/2021 | Yes | No | |
| Results article | fissure sealant retention results | 11/05/2022 | 10/10/2022 | Yes | No |
Editorial Notes
10/10/2022: Publication reference added.
15/06/2021: Publication reference added.
14/05/2021: Trial's existence confirmed by King Saud University.
