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Comparison of Postoperative Sensitivity in Posterior Teeth Using Conventional and Bulkfill Composites

NCT ID: NCT06852586

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-26

Study Completion Date

2023-01-30

Brief Summary

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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

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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.

Conditions

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Class I Dental Caries

Keywords

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Conventional nanohybrid composites, Bulk fill composites

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional Nano-hybrid composites

Coltene Brilliant NG Conventional Nanohybrid composites

Group Type EXPERIMENTAL

conventional nanohybrid composites

Intervention Type DEVICE

Incremental layering technique is used for restoration

Bulk fill composites

Coltene Fillup! Bulk fill COMPOSITES

Group Type EXPERIMENTAL

Bulk fill composites

Intervention Type DEVICE

Single increment in bulk form is applied for restoration

Interventions

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conventional nanohybrid composites

Incremental layering technique is used for restoration

Intervention Type DEVICE

Bulk fill composites

Single increment in bulk form is applied for restoration

Intervention Type DEVICE

Other Intervention Names

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Coltene Brilliant NG conventional Nanohybrid Coltene Fill up! BULKFILL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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28 Military Dental Centre Lahore

OTHER_GOV

Sponsor Role lead

Responsible Party

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Zahra Zubair

Dr Zahra Zubair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zahra Zubair, BDS

Role: PRINCIPAL_INVESTIGATOR

28 Military Dental Centre

Locations

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Zahra Zubir

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 31592052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34129074 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31531552 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33969973 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29594349 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30892408 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34110494 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Other Identifiers

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COMPOSITES

Identifier Type: -

Identifier Source: org_study_id