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

NCT ID: NCT05185206

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-02
• Study Completion Date: 2022-06-30

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.

Conditions

Dental Caries; Dentin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

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.

Group Type: ACTIVE_COMPARATOR

Class 1 cavity preparation using conventional steel bur and restoration with Cention-n(commercially available restorative material).

Intervention Type: 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 polymer bur

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

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).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. D. Y. Patil Dental College & Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soumya Shetty

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Pune, Maharashtra, India

Site Status: RECRUITING

Countries

India

Central Contacts

Soumya S Shetty, MDS

Role: CONTACT

drsoumyasshetty@gmail.com

8888200888

Facility Contacts

Soumya S Shetty, MDS

Role: primary

drsoumyasshetty@gmail.com

888820088

Riya A Parwani, BDS

Role: backup

riyaparwani2307@gmail.com

9922929705

Other Identifiers

DYPDCH/IEC/123/99/19

Identifier Type: -

Identifier Source: org_study_id