Post-operative Sensitivity in Composite Restorations

NCT06092567 | Completed

• 1 other identifier: SOD/ERB/2022/04
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Class II Dental Caries; Sensitivity, Tooth

Outcome Measures

Primary Outcomes (1)

• 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).

  Two weeks

Study Arms (2)

Group A (Oblique Incremental Placement Techniique)

EXPERIMENTAL

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)

Group B (Bulk-fill Placement Technique)

EXPERIMENTAL

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)

Interventions

Group A ( Oblique Incremental Placement Technique) PROCEDURE

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.

Group A (Oblique Incremental Placement Techniique)

Group B (Bulk-fill Placement technique) PROCEDURE

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

Group B (Bulk-fill Placement Technique)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

Study Sites (1)

School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, Pakistan

Location

Related Publications (2)

• 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.

  PMID: 31592052 BACKGROUND

• 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.

  PMID: 31531552 BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Nehal Amir, BDS

  Pakistan Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a double-blinded study in which the participant and the outcome assessor masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: In this study, participants allocated in two groups by Consecutive non-random sampling technique

Study Record Dates

• First Submitted: September 30, 2023
• First Posted: October 23, 2023
• Study Start: December 20, 2022
• Primary Completion: July 24, 2023
• Study Completion: July 24, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)