Post-operative Sensitivity in Composite Restorations

• Sponsor: Pakistan Institute of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT06092567
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.1
• Patients Per Site Per Month: 12.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Class II Dental Caries; Sensitivity, Tooth	Procedure: Group A ( Oblique Incremental Placement Technique); Procedure: Group B (Bulk-fill Placement technique)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: In this study, participants allocated in two groups by Consecutive non-random sampling techniqueIn this study, participants allocated in two groups by Consecutive non-random sampling technique
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: This is a double-blinded study in which the participant and the outcome assessor masked.
• Primary Purpose: Treatment
• Official Title: Post-operative Sensitivity in Composites Using Bulk-fill vs. Oblique Incremental Placement Technique: a Double-blind, Randomized Trial
• Actual Study Start Date: Dec 20, 2022
• Actual Primary Completion Date: Jul 24, 2023
• Actual Study Completion Date: Jul 24, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A (Oblique Incremental Placement Techniique) 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.	Procedure: Group A ( Oblique Incremental Placement Technique); 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.
Experimental: Group B (Bulk-fill Placement Technique) 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.	Procedure: Group B (Bulk-fill Placement technique); 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

Outcome Measures

Primary Outcome Measures

1. Post-operative sensitivity in composite resin restoration [Two weeks]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University	Islamabad		Pakistan

Sponsors and Collaborators

• Pakistan Institute of Medical Sciences

Investigators

• Principal Investigator: Nehal Amir, BDS, Pakistan Institute of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: NEHAL AMIR, Principal Investigator, Pakistan Institute of Medical Sciences
• ClinicalTrials.gov Identifier: NCT06092567
• Other Study ID Numbers: SOD/ERB/2022/04
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 23, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dental Caries; Dentin Sensitivity; Hypersensitivity

Study Results

No Results Posted as of Oct 23, 2023