NCT03792178

Brief Summary

Our study evaluated and compared the postoperative sensitivity of the placement technique (incremental and bulk fill) in class II posterior composite resin restorations bonded with two different adhesive strategies (self-etch and etch-and-rinse).Sixty patients were randomly selected, their age range from 25 to 40 years old. They were divided into 2 main groups according to the packing technique of composite material; incremental Tetric Evoceram and Tetric Evoceram bulk fill composite.30 patients (n=30) were selected for incremental Tetric Evoceram composite restorations and they were equally divided according to the adhesive systems used (etch and rinse or self-etch adhesive strategy) (n=15 teeth).30 patients (n=30) were selected for Tetric Evoceram bulk fill composite restorations and they were equally divided according to the adhesive systems used (etch and rinse or self-etch adhesive strategy) (n=15 teeth).Post-operative pain assessed at 24 hours, 1 week and 1 month using the visual Analog Scale Score (VAS).Each patient was instructed to place a vertical mark on the VAS line at home to indicate the intensity of pain at each assessment period.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
Last Updated

January 7, 2019

Status Verified

January 1, 2019

Enrollment Period

2 days

First QC Date

January 1, 2019

Last Update Submit

January 3, 2019

Conditions

Keywords

Post operative sensitivity

Outcome Measures

Primary Outcomes (1)

  • sensitivity

    post operative sensitivity

    one month follow up

Study Arms (2)

Nano resin composite

ACTIVE COMPARATOR

are types of synthetic resins which are used in dentistry as restorative material or adhesives.

Other: Bulk fill compositeOther: Nano resin composite

Bulk fill composite

EXPERIMENTAL

Bulk- ll composites are claimed to be restorative materials used in deep preparations and effectively photoactivated in layers up to 4 mm.

Other: Bulk fill compositeOther: Nano resin composite

Interventions

Composite resin dental material

Bulk fill compositeNano resin composite

Dental composite material

Bulk fill compositeNano resin composite

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients must show no signs of spontaneous dental or orofacial pain.
  • The presence of molar and premolar class II teeth requiring composite restorations for the treatment of primary carious lesions
  • The selected teeth should have an occlusal contact with natural or crowned antagonist teeth
  • The selected teeth should have a proximal contact with the adjacent teeth.
  • Shallow and mid-sized cavity depths will be included in the study .

You may not qualify if:

  • Increasing pre-operative sensitivity of the selected teeth.
  • Teeth with abnormal periapical anatomy or caries that will be likely to result in very deep restorations.
  • Teeth with old restorations or severely destructed dental crowns.
  • Teeth with spontaneous pain
  • Tempro-mandibular joint problems involving symptomatic pain.
  • Patients taking analgesics that could alter their normal pain perception level.
  • Pregnancy or breast feeding, acute and chronic systemic diseases, immunecompromised patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: bulk fill resin composite placement techqniues versus nano resin composite at postoperative hypersensitivity
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer at operative Department

Study Record Dates

First Submitted

January 1, 2019

First Posted

January 3, 2019

Study Start

September 1, 2016

Primary Completion

September 3, 2016

Study Completion

April 25, 2017

Last Updated

January 7, 2019

Record last verified: 2019-01