Effect of miswak-black silica toothbrush on the color stability and surface roughness of resin composite, resin-modified glass ionomer, and enamel surface, and its remineralization potential: an in vitro and in vivo study
| ISRCTN | ISRCTN98560812 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98560812 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Taibah University |
| Funder | Investigator initiated and funded |
- Submission date
- 22/10/2025
- Registration date
- 31/10/2025
- Last edited
- 29/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study investigates the antibacterial efficacy of a newly designed Miswak-Black Silica toothbrush and its effects on the color stability, surface roughness, and remineralization potential of enamel and restorative materials compared to a conventional soft manual toothbrush.
Who can participate?
Healthy volunteers aged 18–35 years with good oral hygiene
What does the study involve?
Participants will use two different toothbrushes — Miswak-Black Silica and Colgate soft manual toothbrush — each for 1 week, separated by a 1-week washout period. Used brushes will be collected for bacterial culture testing. Laboratory tests will evaluate surface roughness, color change, and remineralization potential.
What are the possible benefits and risks of participating?
There are no direct personal benefits but participation may enhance oral health awareness. Risks are minimal, limited to temporary discomfort, potential mild abrasion or rare allergic reaction.
Where is the study run from?
College of Dentistry, Taibah University, Al-Madinah Al-Munawarah (Saudi Arabia)
When is the study starting and how long is it expected to run for?
May 2025 to April 2026
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Anfal Alqussier, aalqusayr@taibahu.edu.sa
Contact information
Public, Scientific, Principal investigator
KSA, Madinah
Madina
00000
Saudi Arabia
 ORCID ID |
0000-0001-7149-8529 |
|---|---|
| Phone | +966 (0)556622191 |
| aalqusayr@taibahu.edu.sa |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre clinical non-randomized and in vitro comparative laboratory study |
| Secondary study design | Non randomised study |
| Participant information sheet | 48252_ConsentForm_PIS.pdf |
| Scientific title | Effect of miswak-black silica toothbrush on the color stability and surface roughness of resin composite, resin-modified glass ionomer, and enamel surface, and its remineralization potential: an in vitro and in vivo study |
| Study acronym | MIS-BLACK TB |
| Study objectives | 1. To measure the antibacterial effect of Miswak-black Silica toothbrush compared to a soft manual toothbrush (combined in vivo and in vitro) 2. To evaluate the surface roughness of human enamel, resin composite, and resin-modified glass ionomer samples after toothbrushing simulation with Miswak-black Silica toothbrush or Colgate soft manual toothbrush (in vitro) 3. To investigate the color stability of human enamel, resin composite and resin-modified glass ionomer samples after toothbrushing simulation with Miswak-black Silica toothbrush or Colgate soft manual toothbrush (in vitro) 4. To assess the remineralization potential of Miswak-Black Silica Toothbrush on tooth structure (in vitro) |
| Ethics approval(s) |
Approved 13/05/2025, Taibah University College of Dentistry Research Ethics Committee (TUCD-REC) (College of Dentistry, Taibah University, Al-Madinah Al-Munawarah, 0000, Saudi Arabia; +966 (0)14 861 8888; tucdrec@taibahu.edu.sa), ref: TUCDREC202425/Alqussier |
| Health condition(s) or problem(s) studied | Antibacterial effect, surface roughness and color stability of enamel, resin composite, and resin-modified glass ionomer |
| Intervention | Group 1: Miswak-Black Silica toothbrush (Shinyei Kaisha, Japan) used twice daily for 2 minutes without toothpaste for 1 week. Group 2: Colgate soft manual toothbrush used with fluoride toothpaste twice daily for 2 minutes for 1 week. All participants will be instructed to use the conventional (soft) toothbrush with fluoride-containing toothpaste for the first week. Then, after a week washout period, they will be instructed to use the smart toothbrush (miswak/black silica-based toothbrush) for another week (non-randomized study). In vitro component: Enamel and restorative samples brushed for 10,000 cycles (≈1 year simulation). |
| Intervention type | Device |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Miswak-Black Silica toothbrush |
| Primary outcome measure(s) |
Bacterial colony-forming units (CFUs) on toothbrush bristles after 48-hour incubation (Streptococcus mutans) |
| Key secondary outcome measure(s) |
1. Mean surface roughness change (ΔRa) measured with a 3D profilometer before and after brushing simulation |
| Completion date | 20/04/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Total final enrolment | 50 |
| Key inclusion criteria | 1. Adults aged 18–35 years 2. Brushes teeth twice daily 3. Plaque index ≤2 |
| Key exclusion criteria | 1. Open carious lesions 2. Plaque index >2 3. Severe gingivitis (score >2) 4. Throat infection 5. Irregular brushing habits 6. Smoking 7. Medically compromised condition |
| Date of first enrolment | 20/10/2025 |
| Date of final enrolment | 28/02/2026 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
PO Box 344
Al-Madinah Al-Munawwarah
42353
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 during and/or analysed during the current study are not expected to be made available due to participant privacy |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 29/10/2025 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 29/10/2025 | No | No | ||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 48252_PROTOCOL.pdf
- Protocol file
- 48252_ConsentForm_PIS.pdf
- Participant information sheet
Editorial Notes
23/10/2025: Study's existence confirmed by the Taibah University College of Dentistry Research Ethics Committee (TUCD-REC).
