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

NCT05185206 | Unknown

• 1 other identifier: DYPDCH/IEC/123/99/19
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Dentin Sensitivity

Outcome Measures

Primary Outcomes (3)

• 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 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).

  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.

  Post operative sensitivity will be checked after 30 days.

Study Arms (2)

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.

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.

Device: Class 1 cavity preparation using polymer bur and restoration with Cention-n(commercially available restorative material).

Interventions

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).

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). 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).

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. D. Y. Patil Dental College & Hospital: lead

Study Sites (1)

Dr D.Y. Patil Dental College and Hospital, Pimpri

Pune, Maharashtra, 411018, India

RECRUITING

MeSH Terms

Conditions

Dental Caries; Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Soumya S Shetty, MDS

CONTACT

8888200888; drsoumyasshetty@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, investigator and outcome assessor will be blinded to the treatment modalities.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: January 11, 2022
• Study Start: May 2, 2020
• Primary Completion: December 30, 2021
• Study Completion: June 30, 2022
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

IN (1)