Carious LesionNCT05744648
Efficacy of Nanoparticle-incorporated Bonding Agent on Post-restorative Sensitivity
A study testing Composite resin restoration using Titania nanoparticle reinforced bonding agent and Composite resin restoration without Titania nanoparticle incorporated bonding agent in people with Carious Lesion, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
Type of study: Randomized Clinical trial To compare post-restorative sensitivity between titania nanoparticle reinforced bonding agent and bonding agent without nanoparticles in posterior composite restorations. Participants aged 18 years and above with Class-I and Class-II Carious lesions are allocated in two groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carious Lesion
- What is being tested?
- Composite resin restoration using Titania nanoparticle reinforced bonding agent and Composite resin restoration without Titania nanoparticle incorporated bonding agent
- 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
- 5 Jan 2023to 20 Jun 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 good general health
- Selected teeth should be vital and periodontally healthy
- Class-I and II with minimal cavity depth of 3mm, not exceeding 5mm
- Defective previous restorations in need of replacement (secondary caries/fractures)
- Selected teeth should be in occlusion with natural or prosthetic antagonist and adjacent teeth
Who cannot join
- Patients with Temporomandibular disorders
- Extremely poor oral hygiene status
- Teeth with very deep carious lesions
- Teeth with periapical or periodontal pathology
- Patients taking anti-inflammatory, analgesics or psychotropic drugs
- History of spontaneous pain
- Previously root canal treated teeth
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
School of Dentistry, Pakistan Institute of Medical Sciences
Islamabad
About this study
Official title: Clinical Efficacy of a Novel Titania Nanoparticle-Reinforced Bonding Agent in Reducing Post-Restorative Sensitivity: A Randomized Clinical Trial
Type of study: Randomized Clinical trial To compare post-restorative sensitivity between titania nanoparticle reinforced bonding agent and bonding agent without nanoparticles in posterior composite restorations.
Participants aged 18 years and above with Class-I and Class-II Carious lesions are allocated in two groups. Group A will undergo composite restoration with Nanoparticles incorporated in bonding agent. Group B will undergo restoration without nanoparticles in bonding agent.
Read the detailed description
In this study Novel titania nanoparticle reinforced bonding agent will be evaluated for post-restorative sensitivity in composite restorations. Participants following the Inclusion criteria will be allocated in this study by Consecutive non-random sampling technique. Participants will be divided into two groups A and B. After rubber dam isolation, carious lesion will be excavated. In group A, titania nanoparticle reinforced bonding agent will be used for restorative treatment while in group B, Bonding agent without nanoparticles will be used. Post-restorative sensitivity record will be taken at 24 hours, after one week and after one month. Sensitivity will be assessed using Visual analog scale (VAS) mean score.
- Conditions
- Carious Lesion
- Being tested
- Composite resin restoration using Titania nanoparticle reinforced bonding agent, Composite resin restoration without Titania nanoparticle incorporated bonding agent
- Keywords
- Composite resins, Dentin bonding agents, Dentin Sensitivity, Nanoparticles, Titania
- 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.
Composite resin restoration using Titania nanoparticle reinforced bonding agentProcedure or surgery
Each group will receive Composite resin restoration for Class-I and Class-II carious lesion. In group A, titania nanoparticle reinforced bonding agent will be used
Composite resin restoration without Titania nanoparticle incorporated bonding agentProcedure or surgery
Composite resin restoration without Titania nanoparticle incorporated bonding agent
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A will receive composite resin restoration with Titania nanoparticle incorporated bonding agent Receives: Procedure: Composite resin restoration using Titania nanoparticle reinforced bonding agent |
| Group B | Experimental | Group B will receive composite resin restoration without Titania nanoparticle incorporated bonding agent Receives: Procedure: Composite resin restoration without Titania nanoparticle incorporated bonding agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-restorative sensitivity in composite resin restoration
Evaluation of bonding agent with titania nanoparticles and without nanoparticles on post-restorative sensitivity using Visual analog scale with scoring from 0 to 10. Score 10 means worst outcomes
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start5 Jan 2023
- Primary completion20 Jun 2023
- Study completion20 Jun 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 Carious LesionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In this study, participants will be allocated in two groups by Consecutive non-random sampling technique.
- 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, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744648
- Sponsor's protocol ID
- SOD/ERB/2022/14
- Status last verified
- Sep 2023
- First submitted
- 16 Feb 2023
- Last updated
- 13 Sep 2023
- 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 31592280Melo MA, Cheng L, Zhang K, Weir MD, Rodrigues LK, Xu HH. Novel dental adhesives containing nanoparticles of silver and amorphous calcium phosphate. Dent Mater. 2013 Feb;29(2):199-210. doi: 10.1016/j.dental.2012.10.005. Epub 2012 Nov 6.
PubMed 23138046
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of a Novel Titania Nanoparticle-Reinforced Bonding Agent in Reducing Post-Restorative Sensitivity: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05744648
- Acronym / sponsor ID
- SOD/ERB/2022/14
- Conditions
- Carious Lesion
- Keywords
- Composite resins, Dentin bonding agents, Dentin Sensitivity, Nanoparticles, Titania
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 27 Feb 2023 (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.
Type of study: Randomized Clinical trial To compare post-restorative sensitivity between titania nanoparticle reinforced bonding agent and bonding agent without nanoparticles in posterior composite restorations.
Participants aged 18 years and above with Class-I and Class-II Carious lesions are allocated in two groups. Group A will undergo composite restoration with Nanoparticles incorporated in bonding agent. Group B will undergo restoration without nanoparticles in bonding agent.
Detailed description
In this study Novel titania nanoparticle reinforced bonding agent will be evaluated for post-restorative sensitivity in composite restorations. Participants following the Inclusion criteria will be allocated in this study by Consecutive non-random sampling technique. Participants will be divided into two groups A and B. After rubber dam isolation, carious lesion will be excavated. In group A, titania nanoparticle reinforced bonding agent will be used for restorative treatment while in group B, Bonding agent without nanoparticles will be used. Post-restorative sensitivity record will be taken at 24 hours, after one week and after one month. Sensitivity will be assessed using Visual analog scale (VAS) mean score.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-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 non-random sampling technique.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Composite resin restoration using Titania nanoparticle reinforced bonding agentGroup A will receive composite resin restoration with Titania nanoparticle incorporated bonding agent |
| Group B | Experimental | Procedure: Composite resin restoration without Titania nanoparticle incorporated bonding agentGroup B will receive composite resin restoration without Titania nanoparticle incorporated bonding agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants with good general health
- Selected teeth should be vital and periodontally healthy
- Class-I and II with minimal cavity depth of 3mm, not exceeding 5mm
- Defective previous restorations in need of replacement (secondary caries/fractures)
- Selected teeth should be in occlusion with natural or prosthetic antagonist and adjacent teeth
Key exclusion criteria (7 listed)
- Patients with Temporomandibular disorders
- Extremely poor oral hygiene status
- Teeth with very deep carious lesions
- Teeth with periapical or periodontal pathology
- Patients taking anti-inflammatory, analgesics or psychotropic drugs
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 |
|---|---|---|
| Composite resin restoration using Titania nanoparticle reinforced bonding agentEach group will receive Composite resin restoration for Class-I and Class-II carious lesion. In group A, titania nanoparticle reinforced bonding agent will be used | Procedure or surgery | Group A |
| Composite resin restoration without Titania nanoparticle incorporated bonding agentComposite resin restoration without Titania nanoparticle incorporated bonding agent | Procedure or surgery | Group B |
Primary outcome
Post-restorative sensitivity in composite resin restoration
Time frame: 1 month
Evaluation of bonding agent with titania nanoparticles and without nanoparticles on post-restorative sensitivity using Visual analog scale with scoring from 0 to 10. Score 10 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 13 Sep 2023.
- 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.
- Background: PubMed 23138046Melo MA, Cheng L, Zhang K, Weir MD, Rodrigues LK, Xu HH. Novel dental adhesives containing nanoparticles of silver and amorphous calcium phosphate. Dent Mater. 2013 Feb;29(2):199-210. doi: 10.1016/j.dental.2012.10.005. Epub 2012 Nov 6.
- Individual participant dataSharing planned: No
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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
Pakistan Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Composite resin restoration using Titania nanoparticle reinforced bonding agent and Composite resin restoration without Titania nanoparticle incorporated bonding agent in people with Carious Lesion, 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 5 inclusion and 7 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 13 Sep 2023. 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-restorative sensitivity in composite resin restoration (time frame: 1 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 NCT05744648, 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 13 Sep 2023.