NCT04307420

Brief Summary

The aim of this study is to assess the postoperative pain following restoration with composite resin versus sonic fill in children with deep carious first permanent molar.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2020

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

9 months

First QC Date

March 11, 2020

Last Update Submit

July 14, 2020

Conditions

Postoperative Pain

Keywords

First Permanent MolarCompositeSonic FillResin RestorationPediatric Dentistry

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain

    The primary outcome (postoperative pain) is evaluated the following day of the treatment performed by a phone call from the outcome assessor, a week and a month after to check in any pain.

    Baseline

Secondary Outcomes (1)

  • Clinical Evaluation of Restoration (Modified USPHS Criteria)

    3 months, 6 months, 9 months

Study Arms (2)

Sonic Fill Restoration

EXPERIMENTAL

Using sonic activation system turns the highly filled sonic fill composite into a flowable which enables the material to rapidly fill the cavity effortlessly- greatly reducing procedure time.

Procedure: Sonic Fill Restoration

Composite Resin Restoration

ACTIVE COMPARATOR

Direct composite restorations are the most requested and performed dental procedures. The incremental placement technique is the gold standard for posterior universal composite placement.

Procedure: Composite Resin Restoration

Interventions

Sonic Fill RestorationPROCEDURE

Kerr's Sonic Fill is the only sonic-activated, single-step, bulk-fill composite that starts out as a low-viscosity composite.

Sonic Fill Restoration
Composite Resin RestorationPROCEDURE

Composite resins are polymer-based materials used in dentistry for aesthetic repairs.Polymerization is accomplished typically with a hand held curing light that emits specific wavelengths keyed to the initiator and catalyst packages involved.

Composite Resin Restoration

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Asymptomatic First Permanent Molar
  • Age of the patient ranging from 6-9 years
  • Normal periodontal status
  • Teeth with no previous restorative treatment
  • Good oral health
  • Absences of pathological mobility

You may not qualify if:

  • Adverse medical history
  • Potential behavioral problems
  • Parents refusing participation of their children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Chandrasekhar V, Rudrapati L, Badami V, Tummala M. Incremental techniques in direct composite restoration. J Conserv Dent. 2017 Nov-Dec;20(6):386-391. doi: 10.4103/JCD.JCD_157_16.

    PMID: 29430088BACKGROUND

  • 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.

    PMID: 31592052BACKGROUND

  • Atabek D, Aktas N, Sakaryali D, Bani M. Two-year clinical performance of sonic-resin placement system in posterior restorations. Quintessence Int. 2017;48(9):743-751. doi: 10.3290/j.qi.a38855.

    PMID: 28849804RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Nevine Waly, Profesor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Mennatallah S Maklad, Masters

CONTACT

+201015556040menna.maklad@hotmail.com

Fatma K Abdelgawad, Professor

CONTACT

+201006753265fatmadent@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 13, 2020

Study Start

September 1, 2020

Primary Completion

May 31, 2021

Study Completion

June 1, 2021

Last Updated

July 16, 2020

Record last verified: 2020-07