Class IV Dental CariesNCT06220890
Clinical Performance of Two Different Bevel Preparations in Class IV Lesions Using Nanofilled Composite
A study testing Tooth preparation in Class IV lesions with 2mm bevel and Tooth preparation in Class IV lesions with 2mm stair-step chamfer in people with Class IV Dental Caries, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
The purpose of the study is to compare and evaluate clinical performance between two different bevel preparations in Class IV lesions using nano-filled composite restorations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Class IV Dental Caries
- What is being tested?
- Tooth preparation in Class IV lesions with 2mm bevel and Tooth preparation in Class IV lesions with 2mm stair-step chamfer
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 22 Jun 2022to Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age at the time of treatment.
- Class IV lesion in maxillary central incisor, lateral incisor due to fracture or primary/ recurrent caries.
- Patients with complete and normal occlusion and teeth with proximal contacts.
- Patients not having periodontal or pulpal diseases.
- Positive response to the cold test and electric pulp test.
Who cannot join
- Patients with immunocompromised status or debilitating systemic diseases.
- Patients with uncontrolled parafunctional habits.
- Class IV lesion with involvement of pulp.ix
- Class IV lesions with no involvement of dentin.
- Patients presenting extremely poor oral hygiene.
- Patient with high caries index
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Two Different Bevel Preparations in Class IV Lesions Using Nanofilled Composite: A Randomized Clinical Study
The purpose of the study is to compare and evaluate clinical performance between two different bevel preparations in Class IV lesions using nano-filled composite restorations.
Read the detailed description
The main reason for failure in anterior composite restorations is restoration fracture and aesthetic appearance. Restorations in anterior teeth are subjected to high-impact stresses produced through an incisal angle in class IV restorations, require high fracture resistance. It is the biomechanics of restorations that determine their functionality, retention, and functional longevity. Stair-step chamfer preparation is a modification of chamfer preparation that follows the vertical and horizontal anatomical contours, hence, achieves high degree of aesthetics along with exposure of enamel for bonding. According to current literature, no studies have analyzed the clinical performance of different bevel design using direct nano-filled composite resin restorations in Class IV lesions.
Therefore, the aim of this study is to compare and evaluate clinical performance between two different bevel preparations in Class IV lesions using nano-filled composite restorations.
Study will be conducted at Post Graduate Institute of Dental Sciences, Rohtak in Department of Conservative Dentistry \& Endodontics. Time Frame of the study will be 12 months. Patients ≥ 18 years of age with Class IV lesion in maxillary central incisor, lateral incisor due to fracture or primary/ recurrent caries will be enrolled in the study.
After complete carious removal, tooth will be prepared in class IV lesions according to 2mm bevel or 2mm stair-step chamfer preparation group, selective enamel etching and bonding of the tooth using universal adhesive will be done. The cavity will be restored using nanofilled composite by layering technique. The restorations will be undergoing the standard finishing and polishing procedures.
Follow up of patients will be carried out at 3 months for clinical evaluation, 6 and 12 months for both radiographic and clinical evaluation. Restorations will be assessed clinically according to FDI criteria.
- Conditions
- Class IV Dental Caries
- Being tested
- Tooth preparation in Class IV lesions with 2mm bevel, Tooth preparation in Class IV lesions with 2mm stair-step chamfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth preparation in Class IV lesions with 2mm bevelProcedure or surgery
Class IV cavity with 2 mm bevel will be restored with nano-filled composite and clinical performance will be evaluated based on FDI criteria.
Tooth preparation in Class IV lesions with 2mm stair-step chamferProcedure or surgery
Class IV cavity with 2 mm stair step chamfer will be restored with nano-filled composite and clinical performance will be evaluated based on FDI criteria.
| Study group | Role | What they receive |
|---|---|---|
| Class IV lesion with 2 mm bevel (BV) | Experimental | All the enamel margins will be beveled at a 45-degree angle of the width of approximately 2 mm, enamel selectively etched, bonding of tooth using universal adhesive will be done and restored with nano-filled composite. Receives: Procedure: Tooth preparation in Class IV lesions with 2mm bevel |
| Class IV lesion with 2mm stair-step chamfer (SSC) | Experimental | Enamel margins facially will be prepared 2mm deep in stair-step chamfer form, enamel selectively etched, and bonding of tooth using universal adhesive will be done and restored with nano-filled composite. Receives: Procedure: Tooth preparation in Class IV lesions with 2mm stair-step chamfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of 2 mm bevel and stair step chamfer in Class IV lesions using nanofilled composite restorations.
Evaluation of Clinical and radiographic success of class IV lesions with 2mm bevel and stair step chamfer with nanofilled composite restorations will be assessed by FDI criteria.
Measured: 12 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 2024
- Study start22 Jun 2022
- Primary completion25 Mar 2023
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class IV Dental CariesStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Sanjay Tewari, MDS, Study director, POSTGRADUATE INSTITUTE OF DENTAL SCIENCE,ROHTAK ,HARYANA,INDIA,124001
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220890
- Sponsor's protocol ID
- Akankshya Behera
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Two Different Bevel Preparations in Class IV Lesions Using Nanofilled Composite: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06220890
- Acronym / sponsor ID
- Akankshya Behera
- Conditions
- Class IV Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 25 Mar 2023 (actual)
- Study completion
- Mar 2024 (estimated)
- First posted
- 24 Jan 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.
The purpose of the study is to compare and evaluate clinical performance between two different bevel preparations in Class IV lesions using nano-filled composite restorations.
Detailed description
The main reason for failure in anterior composite restorations is restoration fracture and aesthetic appearance. Restorations in anterior teeth are subjected to high-impact stresses produced through an incisal angle in class IV restorations, require high fracture resistance. It is the biomechanics of restorations that determine their functionality, retention, and functional longevity. Stair-step chamfer preparation is a modification of chamfer preparation that follows the vertical and horizontal anatomical contours, hence, achieves high degree of aesthetics along with exposure of enamel for bonding. According to current literature, no studies have analyzed the clinical performance of different bevel design using direct nano-filled composite resin restorations in Class IV lesions.
Therefore, the aim of this study is to compare and evaluate clinical performance between two different bevel preparations in Class IV lesions using nano-filled composite restorations.
Study will be conducted at Post Graduate Institute of Dental Sciences, Rohtak in Department of Conservative Dentistry \& Endodontics. Time Frame of the study will be 12 months. Patients ≥ 18 years of age with Class IV lesion in maxillary central incisor, lateral incisor due to fracture or primary/ recurrent caries will be enrolled in the study.
After complete carious removal, tooth will be prepared in class IV lesions according to 2mm bevel or 2mm stair-step chamfer preparation group, selective enamel etching and bonding of the tooth using universal adhesive will be done. The cavity will be restored using nanofilled composite by layering technique. The restorations will be undergoing the standard finishing and polishing procedures.
Follow up of patients will be carried out at 3 months for clinical evaluation, 6 and 12 months for both radiographic and clinical evaluation. Restorations will be assessed clinically according to FDI criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Class IV lesion with 2 mm bevel (BV) | Experimental | Procedure: Tooth preparation in Class IV lesions with 2mm bevelAll the enamel margins will be beveled at a 45-degree angle of the width of approximately 2 mm, enamel selectively etched, bonding of tooth using universal adhesive will be done and restored with nano-filled composite. |
| Class IV lesion with 2mm stair-step chamfer (SSC) | Experimental | Procedure: Tooth preparation in Class IV lesions with 2mm stair-step chamferEnamel margins facially will be prepared 2mm deep in stair-step chamfer form, enamel selectively etched, and bonding of tooth using universal adhesive will be done and restored with nano-filled composite. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥ 18 years of age at the time of treatment.
- Class IV lesion in maxillary central incisor, lateral incisor due to fracture or primary/ recurrent caries.
- Patients with complete and normal occlusion and teeth with proximal contacts.
- Patients not having periodontal or pulpal diseases.
- Positive response to the cold test and electric pulp test.
Key exclusion criteria (6 listed)
- Patients with immunocompromised status or debilitating systemic diseases.
- Patients with uncontrolled parafunctional habits.
- Class IV lesion with involvement of pulp.ix
- Class IV lesions with no involvement of dentin.
- Patients presenting extremely poor oral hygiene.
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 |
|---|---|---|
| Tooth preparation in Class IV lesions with 2mm bevelClass IV cavity with 2 mm bevel will be restored with nano-filled composite and clinical performance will be evaluated based on FDI criteria. | Procedure or surgery | Class IV lesion with 2 mm bevel (BV) |
| Tooth preparation in Class IV lesions with 2mm stair-step chamferClass IV cavity with 2 mm stair step chamfer will be restored with nano-filled composite and clinical performance will be evaluated based on FDI criteria. | Procedure or surgery | Class IV lesion with 2mm stair-step chamfer (SSC) |
Primary outcome
Clinical performance of 2 mm bevel and stair step chamfer in Class IV lesions using nanofilled composite restorations.
Time frame: 12 months
Evaluation of Clinical and radiographic success of class IV lesions with 2mm bevel and stair step chamfer with nanofilled composite restorations will be assessed by FDI criteria.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
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Evaluate the Shade Matching of Polychromatic Versus Monochromatic Composite Layering Techniques in Fractured Class IV Maxillary Central Incisors Using Universal , Layering & One Shade Composite In-vivo on Patients
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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.
Dr Sanjay Tewari, MDS study director
POSTGRADUATE INSTITUTE OF DENTAL SCIENCE,ROHTAK ,HARYANA,INDIA,124001
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth preparation in Class IV lesions with 2mm bevel and Tooth preparation in Class IV lesions with 2mm stair-step chamfer in people with Class IV Dental Caries, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 6 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: status not confirmed, as of the sponsor's last update on 24 Jan 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 India. 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?
Results are not available in the source record.
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?
Clinical performance of 2 mm bevel and stair step chamfer in Class IV lesions using nanofilled composite restorations. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2024.