Caries,DentalNCT06242184
Post-operative Sensitivity in Resin Composites
A study testing Group A(Nano-fortified Adhesive) and Group B(Adhesive without nanoparticles) in people with Caries,Dental and Sensitivity, Tooth, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
This triple-blind, randomized clinical trial was conducted at the department of Operative dentistry. A total of 60 participants were recruited and were randomly distributed into two groups A and B. After informed consent, restorative treatment was performed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental, Sensitivity, Tooth
- What is being tested?
- Group A(Nano-fortified Adhesive) and Group B(Adhesive without nanoparticles)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2023to 25 Nov 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants with goof general health status
- Class I and II primary Carious lesion with a minimum cavity depth of 3 to 5 mm.
- Vital and Periodontally sound teeth
Who cannot join
- Patient with Temporomandibular dysfunction
- History of spontaneous pain
- Endodontically treated teeth
- Patient on analgesics within the past two weeks
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University
Islamabad
About this study
Official title: Post-operative Sensitivity in Composites Using Bacillus Subtilis Procured Novel Nano-fortified Adhesive: a Triple-blind Study
This triple-blind, randomized clinical trial was conducted at the department of Operative dentistry. A total of 60 participants were recruited and were randomly distributed into two groups A and B. After informed consent, restorative treatment was performed. In group A, adhesive with nanoparticles was used for composite restoration while in group B, adhesive without nanoparticles was utilized. Post-operative sensitivity was recorded using VAS score.
Read the detailed description
Triple-blind, randomized trial, parallel group with an allocation ratio 1:1. A total of 60 participants were recruited from the outpatient department and were randomly distributed into two groups (n=30). After informed consent, restorative treatment was accomplished using an etch and rinse adhesive strategy. In group A , titanium dioxide nano-fortified adhesive was used while in group B, adhesive without nanoparticles was utilized for composite restoration. Post-operative sensitivity was evaluated at follow-up period: one day, one week, two weeks and one month. Visual Analogue scale score was used to record the sensitivity status at follow-up intervals.
- Conditions
- Caries,Dental, Sensitivity, Tooth
- Being tested
- Group A(Nano-fortified Adhesive), Group B(Adhesive without nanoparticles)
- Medical subject headings
- Dental Caries, Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A(Nano-fortified Adhesive)Procedure or surgery
Nano-fortified dentin adhesive
Group B(Adhesive without nanoparticles)Procedure or surgery
Conventional adhesives without nanoparticles
| Study group | Role | What they receive |
|---|---|---|
| Group A (Nano-fortified Adhesive) | Experimental | Titanium dioxide nanoparticles incorporated in dentin adhesive Receives: Procedure: Group A(Nano-fortified Adhesive) |
| Group B (Adhesive without Nanoparticles) | Experimental | Adhesive without nanoparticles Receives: Procedure: Group B(Adhesive without nanoparticles) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative sensitivity
Post-operative sensitivity evaluated at follow-up periods: one day, one week, two weeks and one month using Visual Analogue Scale score with the score 0( none) and score 3( severe sensitivity)
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start15 May 2023
- Primary completion25 Nov 2023
- Study completion25 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Caries,DentalStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, NEHAL AMIR, Pakistan Institute of Medical Sciences
- Investigators
- Nehal Amir, BDS, Principal investigator, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242184
- Sponsor's protocol ID
- NAMIR
- Status last verified
- Feb 2024
- First submitted
- 27 Jan 2024
- Last updated
- 6 Feb 2024
- 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 31592280Amir N, Mansoor A, Eeman N, Ahmed MN, Mansoor E, Hussain K, Palma PJ. Postoperative sensitivity of composites using novel Bacillus subtilis nanofortified adhesives: a triple-blind study. BMC Oral Health. 2024 Sep 12;24(1):1077. doi: 10.1186/s12903-024-04825-2.
PubMed 39267015
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Sensitivity in Composites Using Bacillus Subtilis Procured Novel Nano-fortified Adhesive: a Triple-blind Study
- ClinicalTrials.gov ID
- NCT06242184
- Acronym / sponsor ID
- NAMIR
- Conditions
- Caries,Dental, Sensitivity, Tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 15 May 2023 (actual)
- Primary completion
- 25 Nov 2023 (actual)
- Study completion
- 25 Nov 2023 (actual)
- First posted
- 5 Feb 2024 (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.
This triple-blind, randomized clinical trial was conducted at the department of Operative dentistry. A total of 60 participants were recruited and were randomly distributed into two groups A and B. After informed consent, restorative treatment was performed. In group A, adhesive with nanoparticles was used for composite restoration while in group B, adhesive without nanoparticles was utilized. Post-operative sensitivity was recorded using VAS score.
Detailed description
Triple-blind, randomized trial, parallel group with an allocation ratio 1:1. A total of 60 participants were recruited from the outpatient department and were randomly distributed into two groups (n=30). After informed consent, restorative treatment was accomplished using an etch and rinse adhesive strategy. In group A , titanium dioxide nano-fortified adhesive was used while in group B, adhesive without nanoparticles was utilized for composite restoration. Post-operative sensitivity was evaluated at follow-up period: one day, one week, two weeks and one month. Visual Analogue scale score was used to record the sensitivity status at follow-up intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Nano-fortified Adhesive) | Experimental | Procedure: Group A(Nano-fortified Adhesive)Titanium dioxide nanoparticles incorporated in dentin adhesive |
| Group B (Adhesive without Nanoparticles) | Experimental | Procedure: Group B(Adhesive without nanoparticles)Adhesive without nanoparticles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- participants with goof general health status
- Class I and II primary Carious lesion with a minimum cavity depth of 3 to 5 mm.
- Vital and Periodontally sound teeth
Key exclusion criteria (4 listed)
- Patient with Temporomandibular dysfunction
- History of spontaneous pain
- Endodontically treated teeth
- Patient on analgesics within the past two weeks
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(Nano-fortified Adhesive)Nano-fortified dentin adhesive | Procedure or surgery | Group A (Nano-fortified Adhesive) |
| Group B(Adhesive without nanoparticles)Conventional adhesives without nanoparticles | Procedure or surgery | Group B (Adhesive without Nanoparticles) |
Primary outcome
Post-operative sensitivity
Time frame: One month
Post-operative sensitivity evaluated at follow-up periods: one day, one week, two weeks and one month using Visual Analogue Scale score with the score 0( none) and score 3( severe sensitivity)
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 6 Feb 2024.
- Background: 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.
- Derived from this study: PubMed 39267015Amir N, Mansoor A, Eeman N, Ahmed MN, Mansoor E, Hussain K, Palma PJ. Postoperative sensitivity of composites using novel Bacillus subtilis nanofortified adhesives: a triple-blind study. BMC Oral Health. 2024 Sep 12;24(1):1077. doi: 10.1186/s12903-024-04825-2.
- Individual participant dataSharing planned: No
Related trials for Caries,Dental
Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries
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.
Nehal Amir, BDS principal investigator
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(Nano-fortified Adhesive) and Group B(Adhesive without nanoparticles) in people with Caries,Dental and Sensitivity, Tooth, 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 3 inclusion and 4 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 6 Feb 2024. 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-operative sensitivity (time frame: One month). 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 NCT06242184, which also lists 2 linked publications.
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 6 Feb 2024.