Clinical trial NCT06092567: 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
Overall status: COMPLETED
Phase: NA
Conditions: Class II Dental Caries
Sensitivity, Tooth
Lead sponsor: Pakistan Institute of Medical Sciences
Sponsor class: OTHER_GOV
First posted: 2023-10-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, participants allocated in two groups by Consecutive non-random sampling technique
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Post-operative sensitivity in composite resin restoration
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University
Study officials:
affiliation: Pakistan Institute of Medical Sciences
name: Nehal Amir, BDS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.