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Comparative Evaluation of the Post Operative Sensitivity of Cention-N(Commercially Available Restorative Material) Using Conventional and Polymer Bur- In-vivo Study

Primary Purpose

Dental Caries, Dentin Sensitivity

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
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).
Sponsored by
Dr. D. Y. Patil Dental College & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Dr D.Y. Patil Dental College and Hospital, PimpriRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Analysis of post-operative sensitivity after caries removal using conventional steel bur

Analysis of post-operative sensitivity after caries removal using polymer bur

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2021
Last Updated
January 7, 2022
Sponsor
Dr. D. Y. Patil Dental College & Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05185206
Brief Title
Comparative Evaluation of the Post Operative Sensitivity of Cention-N(Commercially Available Restorative Material) Using Conventional and Polymer Bur- In-vivo Study
Official Title
Comparative Evaluation of the Post Operative Sensitivity of Cention-N(Commercially Available Restorative Material) Using Conventional and Polymer Bur- In-vivo Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. D. Y. Patil Dental College & Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Dentin Sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
The participants, investigator and outcome assessor will be blinded to the treatment modalities.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Analysis of post-operative sensitivity after caries removal using conventional steel bur
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Analysis of post-operative sensitivity after caries removal using polymer bur
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Class 1 cavity preparation using conventional steel bur and restoration with Cention-n(commercially available restorative material).
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Class 1 cavity preparation using polymer bur and restoration with Cention-n(commercially available restorative material).
Intervention Description
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).
Primary Outcome Measure Information:
Title
Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.
Description
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).
Time Frame
Post operative sensitivity will be checked after 24 hours.
Title
Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.
Description
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).
Time Frame
Post operative sensitivity will be checked after 15 days.
Title
Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.
Description
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.
Time Frame
Post operative sensitivity will be checked after 30 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soumya S Shetty, MDS
Phone
8888200888
Email
drsoumyasshetty@gmail.com
Facility Information:
Facility Name
Dr D.Y. Patil Dental College and Hospital, Pimpri
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411018
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soumya S Shetty, MDS
Phone
888820088
Email
drsoumyasshetty@gmail.com
First Name & Middle Initial & Last Name & Degree
Riya A Parwani, BDS
Phone
9922929705
Email
riyaparwani2307@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Comparative Evaluation of the Post Operative Sensitivity of Cention-N(Commercially Available Restorative Material) Using Conventional and Polymer Bur- In-vivo Study

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