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AzTrials

Class I Dental CariesNCT06852586

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

A study testing conventional nanohybrid composites and Bulk fill composites in people with Class I Dental Caries, run by 28 Military Dental Centre Lahore at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Class I Dental Caries
What is being tested?
conventional nanohybrid composites and Bulk fill composites
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
1 sitePakistan
Study dates
26 Aug 2022to 30 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Zahra Zubir

    Lahore, Punjab Province, 042

Other trials in Pakistan

About this study

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.

Read the 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.

Being tested
conventional nanohybrid composites, Bulk fill composites
Keywords
Conventional nanohybrid composites, Bulk fill composites

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • conventional nanohybrid compositesDevice

    Also called Coltene Brilliant NG conventional Nanohybrid

    Incremental layering technique is used for restoration

  • Bulk fill compositesDevice

    Also called Coltene Fill up! BULKFILL

    Single increment in bulk form is applied for restoration

Study groups in NCT06852586
Study groupRoleWhat they receive
Conventional Nano-hybrid compositesExperimentalColtene Brilliant NG Conventional Nanohybrid composites
Receives: Device: conventional nanohybrid composites
Bulk fill compositesExperimentalColtene Fillup! Bulk fill COMPOSITES
Receives: Device: Bulk fill composites

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Avoidance of Postoperative sensitivity in posterior class 1 carious mandibular molars restored with composites

    Numerical Rating Scale

    Measured: 24 hours and 1 week after restoring Class 1 caries

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2025
  2. Study start26 Aug 2022
  3. Primary completion30 Jan 2023
  4. Study completion30 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06852586
Sponsor's protocol ID
COMPOSITES
Status last verified
Jun 2022
First submitted
25 Feb 2025
Last updated
28 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Name, Gender, Age, and Tooth no., Diagnosed class 1 caries

Publications

  • 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.

    PubMed 31592052

  • 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.

    PubMed 34129074

  • 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.

    PubMed 31531552

  • 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.

    PubMed 33969973

  • 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.

    PubMed 29594349

  • 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.

    PubMed 30892408

  • 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.

    PubMed 34110494

  • 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.

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing conventional nanohybrid composites and Bulk fill composites in people with Class I Dental Caries, run by 28 Military Dental Centre Lahore at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Avoidance of Postoperative sensitivity in posterior class 1 carious mandibular molars restored with composites (time frame: 24 hours and 1 week after restoring Class 1 caries). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06852586, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.

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