Dentine HypersensitivityNCT06790953
Efficacy of Novel Titania Nanoparticles Enriched Mouth Wash in Treating Dentine Hypersensitivity
A study testing Group- A Conventional Sensed Mouth Wash and Group-B Novel Titania nanoparticles enriched Mouth Wash in people with Dentine Hypersensitivity, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
Randomized Clinical trial to compare the reduction in dentin hypersensitivity after incorporating biogenically fabricated titania nanoparticles enriched Mouth Wash and Conventional Mouth Wash.Participants ranging between 20-50 years were allocated in two groups. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentine Hypersensitivity
- What is being tested?
- Group- A Conventional Sensed Mouth Wash and Group-B Novel Titania nanoparticles enriched Mouth Wash
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Jun 2024to 3 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants ranging between 20-50 years, good general health but developed dentine sensitivity associated with tooth surface wear and loss during the past 6 months.
- There was no history of allergy.
- Participants did not use any mouth wash , dentifrice or medication in the last 3 months.
- The involved teeth were viable, non-shaky, devoid of any decay, cracks and fillings.
- There was an essential positive response to the provoking Air stimuli.
- These teeth should display the visible signs of tooth loss and wear such as : attrition, abrasion, erosion and abfraction.
Who cannot join
- Participants that might have developed allergy or used medications during the last 2 weeks or more.
- The teeth having cracks, decay and fillings were also excluded. Patients who have undergone any periodontal surgery or gross periodontal issues.
- Participants who used any desensitisizing toothpastes/mouthwashes and tooth bleaching agents within 2 months of the trial were also excluded positively.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
School of Dentistry, Pakistan Institute of Medical Sciences
Islamabad, Punjab Province, 44080
About this study
Official title: Clinical Efficacy of Novel Biogenically Fabricated Titania Nanoparticles Enriched Mouth Wash in Treating the Tooth Dentine Hypersensitivity: A Randamized Clinical Trial
Randomized Clinical trial to compare the reduction in dentin hypersensitivity after incorporating biogenically fabricated titania nanoparticles enriched Mouth Wash and Conventional Mouth Wash.Participants ranging between 20-50 years were allocated in two groups. Group A will use Conventional Mouth Wash without Nanoparticles. Group B will use titania nanoparticles enriched Mouth Wash. Both will use them for three months and then their VAS scoring will be checked.
Read the detailed description
In this study Novel biogenically fabricated titania nanoparticle reinforced Mouth Wash will be evaluated for dentine sensitivity . Participants following Inclusion criteria will be allocated in this study by Consecutive random sampling technique. Participants will be divided into two groups i.e Group-A and Group-B with dentin sensitivity of 30-80. Group A will be given Conventional Mouth Wash for three months and Group-B will be given titania nanoparticles enriched Mouth Wash for three months for the sensitivity. Sensitivity will be assessed using Visual analog scale (VAS) mean score after 1 month and then three months.
- Conditions
- Dentine Hypersensitivity
- Being tested
- Group- A Conventional Sensed Mouth Wash, Group-B Novel Titania nanoparticles enriched Mouth Wash
- Keywords
- Bacillus coagulans, Biogenic, Dentin Hypersensitivity, Nanoparticles, Titanium oxide (TiO2 Nps)
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group- A Conventional Sensed Mouth WashProcedure or surgery
In Group- A Conventional Sensed Mouth Wash will be used for treatment of Dentin hypersensitivity.
Visual Analogue scoring system will be used to calculate the dentin hypersensitivity.
Group-B Novel Titania nanoparticles enriched Mouth WashProcedure or surgery
In Group-B Novel Titania nanoparticles enriched Mouth wash will be used to treat the Dentin hypersensitivity.
Visual Analogue scoring system will be used to calculate the dentin hypersensitivity.
| Study group | Role | What they receive |
|---|---|---|
| Group-A: Conventional Mouth wash . | Experimental | Group A will receive conventional mouthwash for treatment of dentin hypersensitivity Receives: Procedure: Group- A Conventional Sensed Mouth Wash |
| Group-B: Novel Titania nanoparticles Mouth wash | Experimental | Group B will receive novel Titania nano particles reinforced mouthwash for treatment of dentin hypersensitivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post mouth wash utilization Dentine Hypersensitivity
Evaluation of dentine hypersensitivity with Conventional Mouth Wash without titania nanoparticles and Novel Nps Mouth Wash with titania nanoparticles on human tooth dentin. Visual analog scale with scoring from 0 to 100 where Score 100 means worst outcomes.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start13 Jun 2024
- Primary completion3 Dec 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dentine HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, participants will be allocated in two groups by Consecutive random sampling technique
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Afsheen Mansoor, Pakistan Institute of Medical Sciences
- Investigators
- Afsheen Mansoor, PhD, Principal investigator, School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790953
- Sponsor's protocol ID
- SOD/ERB/2024/36-200
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aboelenein AZ, Riad MI, Haridy MF. Effect of a Self-Etch Adhesive Containing Nanobioglass on Postoperative Sensitivity of Posterior Composite Restorations - A Randomized Trial. Open Access Maced J Med Sci. 2019 Jul 25;7(14):2313-2320. doi: 10.3889/oamjms.2019.585. eCollection 2019 Jul 30.
PubMed 31592280
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Novel Biogenically Fabricated Titania Nanoparticles Enriched Mouth Wash in Treating the Tooth Dentine Hypersensitivity: A Randamized Clinical Trial
- ClinicalTrials.gov ID
- NCT06790953
- Acronym / sponsor ID
- SOD/ERB/2024/36-200
- Conditions
- Dentine Hypersensitivity
- Keywords
- Bacillus coagulans, Biogenic, Dentin Hypersensitivity, Nanoparticles, Titanium oxide (TiO2 Nps)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized Clinical trial to compare the reduction in dentin hypersensitivity after incorporating biogenically fabricated titania nanoparticles enriched Mouth Wash and Conventional Mouth Wash.Participants ranging between 20-50 years were allocated in two groups. Group A will use Conventional Mouth Wash without Nanoparticles. Group B will use titania nanoparticles enriched Mouth Wash. Both will use them for three months and then their VAS scoring will be checked.
Detailed description
In this study Novel biogenically fabricated titania nanoparticle reinforced Mouth Wash will be evaluated for dentine sensitivity . Participants following Inclusion criteria will be allocated in this study by Consecutive random sampling technique. Participants will be divided into two groups i.e Group-A and Group-B with dentin sensitivity of 30-80. Group A will be given Conventional Mouth Wash for three months and Group-B will be given titania nanoparticles enriched Mouth Wash for three months for the sensitivity. Sensitivity will be assessed using Visual analog scale (VAS) mean score after 1 month and then three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- In this study, participants will be allocated in two groups by Consecutive random sampling technique
| Arm | Type | Receives |
|---|---|---|
| Group-A: Conventional Mouth wash . | Experimental | Procedure: Group- A Conventional Sensed Mouth WashGroup A will receive conventional mouthwash for treatment of dentin hypersensitivity |
| Group-B: Novel Titania nanoparticles Mouth wash | Experimental | –Group B will receive novel Titania nano particles reinforced mouthwash for treatment of dentin hypersensitivity |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants ranging between 20-50 years, good general health but developed dentine sensitivity associated with tooth surface wear and loss during the past 6 months.
- There was no history of allergy.
- Participants did not use any mouth wash , dentifrice or medication in the last 3 months.
- The involved teeth were viable, non-shaky, devoid of any decay, cracks and fillings.
- There was an essential positive response to the provoking Air stimuli.
Key exclusion criteria (3 listed)
- Participants that might have developed allergy or used medications during the last 2 weeks or more.
- The teeth having cracks, decay and fillings were also excluded. Patients who have undergone any periodontal surgery or gross periodontal issues.
- Participants who used any desensitisizing toothpastes/mouthwashes and tooth bleaching agents within 2 months of the trial were also excluded positively.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group- A Conventional Sensed Mouth WashIn Group- A Conventional Sensed Mouth Wash will be used for treatment of Dentin hypersensitivity. Visual Analogue scoring system will be used to calculate the dentin hypersensitivity. | Procedure or surgery | Group-A: Conventional Mouth wash . |
| Group-B Novel Titania nanoparticles enriched Mouth WashIn Group-B Novel Titania nanoparticles enriched Mouth wash will be used to treat the Dentin hypersensitivity. Visual Analogue scoring system will be used to calculate the dentin hypersensitivity. | Procedure or surgery | – |
Primary outcome
Post mouth wash utilization Dentine Hypersensitivity
Time frame: 3 months
Evaluation of dentine hypersensitivity with Conventional Mouth Wash without titania nanoparticles and Novel Nps Mouth Wash with titania nanoparticles on human tooth dentin. Visual analog scale with scoring from 0 to 100 where Score 100 means worst outcomes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Results publication: PubMed 31592280Aboelenein AZ, Riad MI, Haridy MF. Effect of a Self-Etch Adhesive Containing Nanobioglass on Postoperative Sensitivity of Posterior Composite Restorations - A Randomized Trial. Open Access Maced J Med Sci. 2019 Jul 25;7(14):2313-2320. doi: 10.3889/oamjms.2019.585. eCollection 2019 Jul 30.
- Individual participant dataSharing planned: No
Related trials for Dentine Hypersensitivity
Not yet recruiting
The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations
Dental Restoration Failure, Postoperative Hypersensitivity
Recruiting
A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
Dentin Sensitivity
Active, not recruiting
Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
Tooth Discoloration, Tooth Staining
Recruiting
Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
Dentine Hypersensitivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Afsheen Mansoor, PhD principal investigator
School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group- A Conventional Sensed Mouth Wash and Group-B Novel Titania nanoparticles enriched Mouth Wash in people with Dentine Hypersensitivity, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post mouth wash utilization Dentine Hypersensitivity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06790953, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.