Back to resultsPost-operative Sensitivity in Composite Restorations
Primary Purpose
Class II Dental Caries, Sensitivity, Tooth
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Group A ( Oblique Incremental Placement Technique)
Group B (Bulk-fill Placement technique)
Sponsored by
About this trial
This is an interventional treatment trial for Class II Dental Caries
Eligibility Criteria
Inclusion Criteria: Minimum 18 years of age with good general health Vital and Periodontally stable teeth Class-II primary carious lesions with a cavity depth of 3 to 5 mm Established contact with adjacent and opposing natural or prosthetic teeth Prior defective restorations in need of replacement (secondary caries, marginal fractures, and marginal staining) Exclusion Criteria: Teeth with a history of spontaneous pain Compromised oral health status Patients with parafunctional habits or temporomandibular disorders Previously endodontically treated teeth or evidence of associated periapical/periodontal pathosis Participants with a drug history of using anti-inflammatory, analgesics, or psychotropic medications within the last 2 weeks
Sites / Locations
- School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A (Oblique Incremental Placement Techniique)
Group B (Bulk-fill Placement Technique)
Arm Description
In this interventional group, a Nanohybrid composite resin Nexcomp (Meta Biomed, Korea) was placed using an oblique incremental technique with increments not exceeding 2 mm in thickness.
In this group, a composite Beautifil-Bulk Restorative (SHOFU dental) was utilized for restorative purposes using a bulk-fill technique with a thickness of 4 mm.
Outcomes
Primary Outcome Measures
Post-operative sensitivity in composite resin restoration
Evaluation of post-restorative sensitivity in composite restorations using Visual analogue scale score with scoring from 0 to 10. Score 0 (none), 1 to 3 (mild), 4 to 6 (moderate), and 7 to 10 (severe).
Secondary Outcome Measures
Full Information
NCT ID
NCT06092567
First Posted
September 30, 2023
Last Updated
October 14, 2023
Sponsor
Pakistan Institute of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT06092567
Brief Title
Post-operative Sensitivity in Composite Restorations
Official Title
Post-operative Sensitivity in Composites Using Bulk-fill vs. Oblique Incremental Placement Technique: a Double-blind, Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
July 24, 2023 (Actual)
Study Completion Date
July 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pakistan Institute of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Participants will be divided into groups. In group A, Composite restoration done using oblique incremental technique. In group B, Bulk-fill technique was used. VAS scoring to evaluate the primary outcome at one day, one week and two weeks.
Detailed Description
After the approval from ethical research committee, a written informed consent taken. Participants were briefed about the intervention with its associated merits and demerits. The restorative procedures were accomplished under rubber dam isolation using adequate local anesthesia. The principles of minimally intervention and adhesive dentistry were employed. Participants were allocated into two groups. In group A, restorative interventive was performed using Oblique incremental placement while in group B, Bulk-fill technique was used. Post-operative sensitivity was recorded at one day, one week and two week follow up using a Visual analogue scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Dental Caries, Sensitivity, Tooth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this study, participants allocated in two groups by Consecutive non-random sampling technique
Masking
ParticipantOutcomes Assessor
Masking Description
This is a double-blinded study in which the participant and the outcome assessor masked.
Allocation
Non-Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (Oblique Incremental Placement Techniique)
Arm Type
Experimental
Arm Description
In this interventional group, a Nanohybrid composite resin Nexcomp (Meta Biomed, Korea) was placed using an oblique incremental technique with increments not exceeding 2 mm in thickness.
Arm Title
Group B (Bulk-fill Placement Technique)
Arm Type
Experimental
Arm Description
In this group, a composite Beautifil-Bulk Restorative (SHOFU dental) was utilized for restorative purposes using a bulk-fill technique with a thickness of 4 mm.
Intervention Type
Procedure
Intervention Name(s)
Group A ( Oblique Incremental Placement Technique)
Intervention Description
In this interventional group, a Nanohybrid composite resin Nexcomp (Meta Biomed, Korea) was placed using an oblique incremental technique with increments not exceeding 2 mm in thickness.
Intervention Type
Procedure
Intervention Name(s)
Group B (Bulk-fill Placement technique)
Intervention Description
In this group, a composite Beautifil-Bulk Restorative (SHOFU dental) was utilized for restorative purposes using a bulk-fill technique with a thickness of 4 mm
Primary Outcome Measure Information:
Title
Post-operative sensitivity in composite resin restoration
Description
Evaluation of post-restorative sensitivity in composite restorations using Visual analogue scale score with scoring from 0 to 10. Score 0 (none), 1 to 3 (mild), 4 to 6 (moderate), and 7 to 10 (severe).
Time Frame
Two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Minimum 18 years of age with good general health
Vital and Periodontally stable teeth
Class-II primary carious lesions with a cavity depth of 3 to 5 mm
Established contact with adjacent and opposing natural or prosthetic teeth
Prior defective restorations in need of replacement (secondary caries, marginal fractures, and marginal staining)
Exclusion Criteria:
Teeth with a history of spontaneous pain
Compromised oral health status
Patients with parafunctional habits or temporomandibular disorders
Previously endodontically treated teeth or evidence of associated periapical/periodontal pathosis
Participants with a drug history of using anti-inflammatory, analgesics, or psychotropic medications within the last 2 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nehal Amir, BDS
Organizational Affiliation
Pakistan Institute of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University
City
Islamabad
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31592052
Citation
Afifi SMH, Haridy MF, Farid MR. Evaluation of Post-Operative Sensitivity of Bulk Fill Resin Composite versus Nano Resin Composite: A Randomized Controlled Clinical Study. Open Access Maced J Med Sci. 2019 Jul 26;7(14):2335-2342. doi: 10.3889/oamjms.2019.656. eCollection 2019 Jul 30.
Results Reference
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PubMed Identifier
31531552
Citation
Tardem C, Albuquerque EG, Lopes LS, Marins SS, Calazans FS, Poubel LA, Barcelos R, Barceleiro MO. Clinical time and postoperative sensitivity after use of bulk-fill (syringe and capsule) vs. incremental filling composites: a randomized clinical trial. Braz Oral Res. 2019 Sep 16;33(0):e089. doi: 10.1590/1807-3107bor-2019.vol33.0089.
Results Reference
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Post-operative Sensitivity in Composite Restorations
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