Comparison of two dental isolation tools used during routine procedures: Rubber Dam and OptiDam
| ISRCTN | ISRCTN53192171 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53192171 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | HAPO-02-K-012-2024-12-2377 |
| Sponsor | Umm al-Qura University |
| Funder | Investigator initiated and funded |
- Submission date
- 15/07/2025
- Registration date
- 18/07/2025
- Last edited
- 12/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study aims to compare the ease of application, time for placement, patient satisfaction, and comfort during common use of the OptiDam versus the conventional rubber dam (CRD) in routine dental practice at Umm Al-Qura University Dental Teaching Hospital.
Who can participate?
Patients receiving dental treatment at Umm Al-Qura University Dental Teaching Hospital
What does the study involve?
Participants are randomly allocated to be treated with Rubber Dam or OptiDam during their dental treatment.
What are the possible benefits and risks of participating?
The possible benefits include improved comfort and efficiency, enhanced quality of care, and contribution to dental research with no extra costs. The risks involved are minimal and similar to those associated with the use of rubber dams in standard dental procedures. If you experience discomfort, the rubber dam can be adjusted or removed.
Where is the study run from?
Umm Al-Qura University (Saudi Arabia)
When is the study starting and how long is it expected to run for?
December 2024 to August 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Rashed Binqali, s441007974@uqu.edu.sa
Contact information
Principal investigator
Makkah
Makkah
24221
Saudi Arabia
| Phone | +966 (0)553355708 |
|---|---|
| ombukhari@uqu.edu.sa |
Public, Scientific
Makkah
Makkah
24211
Saudi Arabia
| Phone | +966 (0)54961752 |
|---|---|
| s441007974@uqu.edu.sa |
Public
Makkah
Makkah
24261
Saudi Arabia
| Phone | +966 (0)599160515 |
|---|---|
| s441001990@uqu.edu.sa |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A clinical comparison of the Rubber Dam and OptiDam in routine dental procedures at Umm Al-Qura University Dental Hospital |
| Study objectives | Compare between two isolation systems: 1. Ease of application 2. Time for placement 3. Patient satisfaction 4. Patient comfort |
| Ethics approval(s) |
Approved 09/12/2024, Umm Al-Qura University Faculty of Dentistry Biomedical Research Ethics Committee (Taif Road, Al-abdiyyah, Makkah, 24353, Saudi Arabia; +966 (0)125270000; cscenter@uqu.edu.sa), ref: JTIR141124 |
| Health condition(s) or problem(s) studied | Moisture control during dental procedures |
| Intervention | Patients will be assigned to one of two groups (1:1) using computer-generated randomisation: 1. Conventional rubber dam (control group ) 2. OptiDam (intervention group) Treatment duration: each procedure will last 1 to 2 hours. Follow-up duration: immediate post-procedure evaluation only. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Time to place isolation system, recorded by using a stopwatch starting at the initiation of isolation placement and ending when the isolation is stable in place and the tooth is ready for treatment |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 17/08/2025 |
Eligibility
| Participant type(s) | Patient, Learner/student |
|---|---|
| Age group | Mixed |
| Lower age limit | 15 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Total final enrolment | 114 |
| Key inclusion criteria | 1. Systematically healthy patients: American Society of Anesthesiologists (ASA) I or Controlled ASA II 2. Undergoing routine dental procedures |
| Key exclusion criteria | 1. Latex allergy 2. Severe gag reflex |
| Date of first enrolment | 10/12/2024 |
| Date of final enrolment | 07/08/2025 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Al-Abdiyyah
Makkah
24243
Saudi Arabia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated and/or analyzed during the current study are not expected to be made available, as the data can be verified for only validity purposes if required by an authority that has the right to check our result upon request from the author, Rashed Binqali. The data is quantitative data and will be stored in Dr. Omair M. Bukhari's office at Umm Al-Qura University for two years. The data can be accessed by the research team only. All data was taken from the participants after signing an electronic consent to use their data for the purpose of this study only. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/09/2025: The following changes were made to the study record:
1. The date of first enrolment was changed from 01/09/2025 to 07/08/2025.
2. The completion date was changed from 11/11/2025 to 17/08/2025.
3. The target number of participants was changed from 100 to 120.
4. Total final enrolment added.
15/07/2025: Study's existence confirmed by the Umm Al-Qura University Faculty of Dentistry Biomedical Research Ethics Committee.
