Clinical trial NCT06852586: Comparison of Postoperative Sensitivity in Posterior Teeth Using Conventional and Bulkfill Composites
Official title: Comparison of Postoperative Sensitivity in Posterior Teeth Using Conventional and Bulkfill Composites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class I Dental Caries
Keywords: Conventional nanohybrid composites, Bulk fill composites
Lead sponsor: 28 Military Dental Centre Lahore
Sponsor class: OTHER_GOV
First posted: 2025-02-28
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the onset and severity of pain and postoperative sensitivity in patients after using conventional nanohybrid and bulkfill composites

Null Hypothesis:

There is no significant difference in mean postoperative sensitivity exhibited with conventional nano-hybrid versus bulkfill composites in mandibular molars with class 1 cavity.

Detailed description: The study will include 79 patients with class 1 carious mandibular molars. Teeth are divided into two groups based on composite placement techniques. In group 1, 39 patients are restored with conventional nanohybrid composites using an incremental layering technique. In group 2, 40 patients are restored with bulk-fill composites containing a single increment. After taking a brief history, informed consent will be taken from patients. The depth of the cavity will be determined using a periodontal probe not extending more than 3 mm. Preoperatively, pulp vitality will be assessed using the cold thermal test. A preoperative radiograph will also be taken. A rubber dam will be used. The cavity will be prepared and a selective etch technique will be used. Patients will be recalled after 24 hours and 1 week, thermal cold tests will be performed and a questionnaire containing the Numerical Rating Scale will be given to each patient for evaluation of post-operative pain felt after 24 hours and 1 week.

Eligibility criteria: Inclusion Criteria:

- 1. Patients with ages range from 18- 55 years. 2. Male/ Female. 3. Mandibular molars with class 1 shallow-sized cavity with no history of pre-operative pain or sensitivity.

4. Ability to understand the use of pain and sensitivity scale. 5. Patients with adequate oral hygiene and willingness to participate in this study.

Exclusion Criteria:

- 1. Patients with deep caries of tooth associated with pain and sensitivity. 2. Patients who have consumed any type of medication before treatment. 3. Periapical pathologies (periapical abscess, sinus tract, periapical cyst, pulpal abscess.

4. Unfavorable location of the tooth, severe tooth malposition, and trismus.

Primary outcomes:
measure: Avoidance of Postoperative sensitivity in posterior class 1 carious mandibular molars restored with composites
timeFrame: 24 hours and 1 week after restoring Class 1 caries
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Zahra Zubir
state: Punjab
Study officials:
affiliation: 28 Military Dental Centre
name: Zahra Zubair, 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: Cieplik F, Scholz KJ, Anthony JC, Tabenski I, Ettenberger S, Hiller KA, Buchalla W, Federlin M. One-year results of a novel self-adhesive bulk-fill restorative and a conventional bulk-fill composite in class II cavities-a randomized clinical split-mouth study. Clin Oral Investig. 2022 Jan;26(1):449-461. doi: 10.1007/s00784-021-04019-y. Epub 2021 Jun 15.
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.
citation: Chiodera G, Orsini G, Tosco V, Monterubbianesi R, Manauta J, Devoto W, Putignano A. Essential Lines: a simplified filling and modeling technique for direct posterior composite restorations. Int J Esthet Dent. 2021 May 10;16(2):168-184.
citation: Veloso SRM, Lemos CAA, de Moraes SLD, do Egito Vasconcelos BC, Pellizzer EP, de Melo Monteiro GQ. Clinical performance of bulk-fill and conventional resin composite restorations in posterior teeth: a systematic review and meta-analysis. Clin Oral Investig. 2019 Jan;23(1):221-233. doi: 10.1007/s00784-018-2429-7. Epub 2018 Mar 28.
citation: Nascimento AS, Rodrigues JFB, Torres RHN, Santos KO, Fook MVL, Albuquerque MS, Lima EA, Filgueira PTD, Santos JBMD, Oliveira LJR, Braz R. Physicomechanical and thermal analysis of bulk-fill and conventional composites. Braz Oral Res. 2019 Mar 18;33:e008. doi: 10.1590/1807-3107bor-2019.vol33.0008.
citation: Yazici AR, Kutuk ZB, Ergin E, Karahan S, Antonson SA. Six-year clinical evaluation of bulk-fill and nanofill resin composite restorations. Clin Oral Investig. 2022 Jan;26(1):417-426. doi: 10.1007/s00784-021-04015-2. Epub 2021 Jun 10.
citation: Burke FJT, Mackenzie L. Bonding to dentine: an update on universal adhesives. Dent Update. 2021;48(8):620-31. doi: 10.12968/denu.2021.48.8.620.
citation: Burke FJT, Mackenzie L, Sands P, Shortall ACC. Ten tips for avoiding post-operative sensitivity with posterior composite restorations. Dent Update. 2021;48(10):823-32. DOI: 10.12968/denu.2021.48.10.823.