Dental CariesNCT05185206
Comparative Evaluation of the Post Operative Sensitivity of Cention-N(Commercially Available Restorative Material) Using Conventional and Polymer Bur- In-vivo Study
A study testing Class 1 cavity preparation using conventional steel bur and restoration with Cention-n(commercially available restorative material). and Class 1 cavity preparation using polymer bur and restoration with Cention-n(commercially available restorative material). in people with Dental Caries and Dentin Sensitivity, run by Dr. D. Y. Patil Dental College & Hospital at 1 site in India.
Trial summary
Cention-N(commercially available restorative material) is a cost effective restoration for posterior restorations. Post-operative sensitivity is of great concern as far as any type of restorative material is concerned. Reduction of post-operative sensitivity is still a major on-going research. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Dentin Sensitivity
- What is being tested?
- Class 1 cavity preparation using conventional steel bur and restoration with Cention-n(commercially available restorative material). and Class 1 cavity preparation using polymer bur and restoration with Cention-n(commercially available restorative material).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 2 May 2020to 30 Jun 2022
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged between 18 and 55 years having class 1 occlusal caries(1.2 according to G. J. Mount classification) on both sides of arch. In order to standardise the cavity preparation depth(approximately 1.5 to 2mm from the roof of the pulp chamber), the distance from occlusal surface to roof of pulp chamber will be used for measuring with the radiograph.
- Roots with closed apex.
- Systematically healthy patients.
- Patients with no other symptomatic tooth involved
Who cannot join
- Teeth with the presence of any pathologic pulpal disease with or without pain.
- Teeth with previous restorations, any defective restoration adjacent to or opposing the affected tooth.
- Teeth with surface loss due to attrition, erosion, abrasion, or abfraction.
- Patients with poor oral hygiene, severe, or chronic periodontitis.
- Patient on medication which may hinder the response to sensitivity.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Dr D.Y. Patil Dental College and Hospital, Pimpri
Pune, Maharashtra, 411018
Soumya S Shetty, MDS, 888820088, drsoumyasshetty@gmail.com
Riya A Parwani, BDS, 9922929705, riyaparwani2307@gmail.com
About this study
Cention-N(commercially available restorative material) is a cost effective restoration for posterior restorations. Post-operative sensitivity is of great concern as far as any type of restorative material is concerned. Reduction of post-operative sensitivity is still a major on-going research. Timely advancement has lead to the discovery and usage of polymer bur for reduction of excess tooth removal, and thus reduction of sensitivity. Therefore the novelty of this study is comparision of the post operative sensitivity of Cention-N(commercially available restorative material) using conventional and polymer bur using Visual Analog Scale.
Read the detailed description
Dental caries is a multifactorial disease which is very much prevalent in India occurring especially in high economic group and some in middle and lower economic groups of world population.The most common instruments used for excavation of dental caries are the use of diamond and carbide burs.There is effective removal of the carious tooth structure through these burs which leads to excess removal of tooth structure and weakening the teeth.
Timely advancement in dentistry and the quest for the development of ideal esthetic materials to replace lost dental tissue has led to use of Cention-N(commercially available restorative material) to restore posterior teeth. Cention N(commerically available restorative material) is a recently introduced tooth-coloured, basic filling material for bulk placement in retentive preparations with or without the application of an adhesive. It is an alkise restorative which is a new category of filling material, like compomer(commercially available restorative material) or ormocer(commercially available restorative material) and is essentially a subgroup of the composite resin. Cention-N(commercially available restorative material)offers a cost-effective substitute for amalgam and also fulfills the need of an esthetic bulk fill material in the posterior region. Patients have described post-operative sensitivity as a moderate pain, of short duration, that appears spontaneously when chewing, with hot and cold foods and on rare occasions with sweet and acid foods, and it disappears when the stimulus is removed. It is characterized by an acute pain that can last for days or weeks and disappears when the stimulus is removed.It results from the interaction between the restorative technique, the clinical condition of the tooth to be treated (health of the pulp and remaining hard dental tissue) and the restorative material. Therefore, there is a permanent and unpredictable possibility of sensitivity occurring. In addition, there are other factors related to the cause of post- operative sensitivity, such as the individual profile of each patient, the shape and extension of the cavity preparation and protection of the dentin-pulp complex. Hence the novelty of this study is to evaluate of the post operative sensitivity of Cention-n (commerically available restorative material)using conventional and polymer bur.
- Conditions
- Dental Caries, Dentin Sensitivity
- Being tested
- Class 1 cavity preparation using conventional steel bur and restoration with Cention-n(commercially available restorative material)., Class 1 cavity preparation using polymer bur and restoration with Cention-n(commercially available restorative material).
- 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.
Class 1 cavity preparation using conventional steel bur and restoration with Cention-n(commercially available restorative material).Device
Patients aged between 18 and 55 years having class 1 occlusal caries(1.2 according to G. J. Mount classification) on both sides of arch. In order to standardise the cavity preparation depth(approximately 1.5 to 2mm from the roof of the pulp chamber), the distance from occlusal surface to roof of pulp chamber will be used for measuring with the radiograph. This will be followed by caries removal with convention steel bur followed by restoration with Cention-n and checking of postoperative sensitivity using Visual Analog Scale.The Visual Analog Scale consists of a 100-mm line divided into equal intervals of 10 mm, where 0 represents "absence of pain" and 100 "severe pain." The results of Visual Analog Scale will be classified as mild (0-30 mm), moderate (40-70 mm), or severe pain (> 70 mm).
Class 1 cavity preparation using polymer bur and restoration with Cention-n(commercially available restorative material).Device
Patients aged between 18 and 55 years having class 1 occlusal caries(1.2 according to G. J. Mount classification) on both sides of arch. In order to standardise the cavity preparation depth(approximately 1.5 to 2mm from the roof of the pulp chamber), the distance from occlusal surface to roof of pulp chamber will be used for measuring with the radiograph. This will be followed by caries removal with polymer bur followed by restoration with Cention-n and checking of postoperative sensitivity using Visual Analog scale.The Visual Analog Scale consists of a 100-mm line divided into equal intervals of 10 mm, where 0 represents "absence of pain" and 100 "severe pain." The results of Visual Analog Scale will be classified as mild (0-30 mm), moderate (40-70 mm), or severe pain (> 70 mm).
| Study group | Role | What they receive |
|---|---|---|
| Analysis of post-operative sensitivity after caries removal using conventional steel bur | Active comparator | Caries will be excavated using a carbide on one side of the arch and restoration will be done with Cention-N(commercially available restorative material) as per manufacturer's instructions.Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the Visual Analog Scale. Receives: Device: Class 1 cavity preparation using conventional steel bur and restoration with Cention-n(commercially available restorative material). |
| Analysis of post-operative sensitivity after caries removal using polymer bur | Experimental | Caries will be excavated using a polymer on one side of the arch and restoration will be done with Cention-N(commercially available restorative material) as per manufacturer's instructions.Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the Visual Analog Scale. Receives: Device: Class 1 cavity preparation using polymer bur and restoration with Cention-n(commercially available restorative material). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.
Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the visual analog scale (VAS).
Measured: Post operative sensitivity will be checked after 24 hours.
Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.
Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the visual analog scale (VAS).
Measured: Post operative sensitivity will be checked after 15 days.
Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.
Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the Visual Analog Scale.
Measured: Post operative sensitivity will be checked after 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start2 May 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- A split mouth study design which checks the post operative sensitivity with cention-n(commercially available restorative material) using conventional steel bur and polymer bur using Visual Analog scale.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. D. Y. Patil Dental College & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soumya Shetty, Dr. D. Y. Patil Dental College & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185206
- Sponsor's protocol ID
- DYPDCH/IEC/123/99/19
- Status last verified
- Jan 2022
- First submitted
- 12 Dec 2021
- Last updated
- 11 Jan 2022
- 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 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Post Operative Sensitivity of Cention-N(Commercially Available Restorative Material) Using Conventional and Polymer Bur- In-vivo Study
- ClinicalTrials.gov ID
- NCT05185206
- Acronym / sponsor ID
- DYPDCH/IEC/123/99/19
- Conditions
- Dental Caries, Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dr. D. Y. Patil Dental College & HospitalUniversity, hospital or other
- Study start
- 2 May 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 11 Jan 2022 (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.
Cention-N(commercially available restorative material) is a cost effective restoration for posterior restorations. Post-operative sensitivity is of great concern as far as any type of restorative material is concerned. Reduction of post-operative sensitivity is still a major on-going research. Timely advancement has lead to the discovery and usage of polymer bur for reduction of excess tooth removal, and thus reduction of sensitivity. Therefore the novelty of this study is comparision of the post operative sensitivity of Cention-N(commercially available restorative material) using conventional and polymer bur using Visual Analog Scale.
Detailed description
Dental caries is a multifactorial disease which is very much prevalent in India occurring especially in high economic group and some in middle and lower economic groups of world population.The most common instruments used for excavation of dental caries are the use of diamond and carbide burs.There is effective removal of the carious tooth structure through these burs which leads to excess removal of tooth structure and weakening the teeth.
Timely advancement in dentistry and the quest for the development of ideal esthetic materials to replace lost dental tissue has led to use of Cention-N(commercially available restorative material) to restore posterior teeth. Cention N(commerically available restorative material) is a recently introduced tooth-coloured, basic filling material for bulk placement in retentive preparations with or without the application of an adhesive. It is an alkise restorative which is a new category of filling material, like compomer(commercially available restorative material) or ormocer(commercially available restorative material) and is essentially a subgroup of the composite resin. Cention-N(commercially available restorative material)offers a cost-effective substitute for amalgam and also fulfills the need of an esthetic bulk fill material in the posterior region. Patients have described post-operative sensitivity as a moderate pain, of short duration, that appears spontaneously when chewing, with hot and cold foods and on rare occasions with sweet and acid foods, and it disappears when the stimulus is removed. It is characterized by an acute pain that can last for days or weeks and disappears when the stimulus is removed.It results from the interaction between the restorative technique, the clinical condition of the tooth to be treated (health of the pulp and remaining hard dental tissue) and the restorative material. Therefore, there is a permanent and unpredictable possibility of sensitivity occurring. In addition, there are other factors related to the cause of post- operative sensitivity, such as the individual profile of each patient, the shape and extension of the cavity preparation and protection of the dentin-pulp complex. Hence the novelty of this study is to evaluate of the post operative sensitivity of Cention-n (commerically available restorative material)using conventional and polymer bur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A split mouth study design which checks the post operative sensitivity with cention-n(commercially available restorative material) using conventional steel bur and polymer bur using Visual Analog scale.
| Arm | Type | Receives |
|---|---|---|
| Analysis of post-operative sensitivity after caries removal using conventional steel bur | Active comparator | Device: Class 1 cavity preparation using conventional steel bur and restoration with Cention-n(commercially available restorative material).Caries will be excavated using a carbide on one side of the arch and restoration will be done with Cention-N(commercially available restorative material) as per manufacturer's instructions.Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the Visual Analog Scale. |
| Analysis of post-operative sensitivity after caries removal using polymer bur | Experimental | Device: Class 1 cavity preparation using polymer bur and restoration with Cention-n(commercially available restorative material).Caries will be excavated using a polymer on one side of the arch and restoration will be done with Cention-N(commercially available restorative material) as per manufacturer's instructions.Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the Visual Analog Scale. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged between 18 and 55 years having class 1 occlusal caries(1.2 according to G. J. Mount classification) on both sides of arch. In order to standardise the cavity preparation depth(approximately 1.5 to 2mm from the roof of the pulp chamber), the distance from occlusal surface to roof of pulp chamber will be used for measuring with the radiograph.
- Roots with closed apex.
- Systematically healthy patients.
- Patients with no other symptomatic tooth involved
Key exclusion criteria (5 listed)
- Teeth with the presence of any pathologic pulpal disease with or without pain.
- Teeth with previous restorations, any defective restoration adjacent to or opposing the affected tooth.
- Teeth with surface loss due to attrition, erosion, abrasion, or abfraction.
- Patients with poor oral hygiene, severe, or chronic periodontitis.
- Patient on medication which may hinder the response to sensitivity.
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 |
|---|---|---|
| Class 1 cavity preparation using conventional steel bur and restoration with Cention-n(commercially available restorative material).Patients aged between 18 and 55 years having class 1 occlusal caries(1.2 according to G. J. Mount classification) on both sides of arch. In order to standardise the cavity preparation depth(approximately 1.5 to 2mm from the roof of the pulp chamber), the distance from occlusal surface to roof of pulp chamber will be used for measuring with the radiograph. This will be followed by caries removal with convention steel bur followed by restoration with Cention-n and checking of postoperative sensitivity using Visual Analog Scale.The Visual Analog Scale consists of a 100-mm line divided into equal intervals of 10 mm, where 0 represents "absence of pain" and 100 "severe pain." The results of Visual Analog Scale will be classified as mild (0-30 mm), moderate (40-70 mm), or severe pain (> 70 mm). | Device | Analysis of post-operative sensitivity after caries removal using conventional steel bur |
| Class 1 cavity preparation using polymer bur and restoration with Cention-n(commercially available restorative material).Patients aged between 18 and 55 years having class 1 occlusal caries(1.2 according to G. J. Mount classification) on both sides of arch. In order to standardise the cavity preparation depth(approximately 1.5 to 2mm from the roof of the pulp chamber), the distance from occlusal surface to roof of pulp chamber will be used for measuring with the radiograph. This will be followed by caries removal with polymer bur followed by restoration with Cention-n and checking of postoperative sensitivity using Visual Analog scale.The Visual Analog Scale consists of a 100-mm line divided into equal intervals of 10 mm, where 0 represents "absence of pain" and 100 "severe pain." The results of Visual Analog Scale will be classified as mild (0-30 mm), moderate (40-70 mm), or severe pain (> 70 mm). | Device | Analysis of post-operative sensitivity after caries removal using polymer bur |
Primary outcome
Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.
Time frame: Post operative sensitivity will be checked after 24 hours.
Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the visual analog scale (VAS).
Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.
Time frame: Post operative sensitivity will be checked after 15 days.
Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the visual analog scale (VAS).
Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.
Time frame: Post operative sensitivity will be checked after 30 days.
Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity. The pain intensity will be recorded with the Visual Analog Scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Class 1 cavity preparation using conventional steel bur and restoration with Cention-n(commercially available restorative material). and Class 1 cavity preparation using polymer bur and restoration with Cention-n(commercially available restorative material). in people with Dental Caries and Dentin Sensitivity, run by Dr. D. Y. Patil Dental College & Hospital 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 4 inclusion and 5 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 11 Jan 2022. 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?
Contact Soumya S Shetty, MDS (8888200888, drsoumyasshetty@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus. (time frame: Post operative sensitivity will be checked after 24 hours.). The study lists 3 primary outcomes in all. 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 11 Jan 2022.