Post-operative Sensitivity in Composite Restorations

Sensitivity, Tooth Clinical Trial

Official title:

Post-operative Sensitivity in Composites Using Bulk-fill vs. Oblique Incremental Placement Technique: a Double-blind, Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06092567
• Other study ID #: SOD/ERB/2022/04
• Status: Completed
• Phase: N/A
• Start date: December 20, 2022
• Est. completion date: July 24, 2023

Study information

• Verified date: October 2023
• Source: Pakistan Institute of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 24, 2023
• Est. primary completion date: July 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Class II Dental Caries
• Dental Caries
• Dentin Sensitivity
• Hypersensitivity
• Sensitivity, Tooth

Intervention

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.
• 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

Locations

Country	Name	City	State
Pakistan	School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Medical Sciences

Country where clinical trial is conducted

Pakistan, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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