NCT02093091

Brief Summary

This clinical trial was performed to evaluate the nano-filled resin modified glass ionomer (RMGI) -with a brand name of "Ketac Nano"- as a filling material for the treatment of caries in primary teeth. Children aged 5-8 years were selected and treated with either Ketac Nano or another conventional RMGI called Vitremer. Then, the treated children were evaluated at baseline, after one yeat and after two years. The hypothesis to be tested in the present study was: The clinical performance of nano-filled RMGI (Ketac Nano) in class I primary molars will differ from that of its preceding conventional RMGI (Vitremer).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
Last Updated

March 20, 2014

Status Verified

March 1, 2014

Enrollment Period

4 months

First QC Date

March 11, 2014

Last Update Submit

March 17, 2014

Conditions

Dental Caries

Keywords

nano-filled resin modified glass ionomerclinical performanceclass Iprimary teethdentin bond strengthFilling of class I

Outcome Measures

Primary Outcomes (1)

  • Evidence of clinically definite deterioration of the evaluated filling materials at specific characters (parameters); marginal discoloration, marginal adaptation, color match, anatomic form and recurrent caries.

    The filling materials were blindly evaluated by two trained investigators at specific characters or parameters according to the modified United States Public Health Service (USPHS). Each parameter has three grades of evaluation; Alfa (A), Bravo (B) and Charlie (C) that represent the degree of deterioration of the filling materials.

    2 years

Study Arms (2)

Vitremer

SHAM COMPARATOR

Dental caries was removed from primary molars and was filled with the conventional filling material;Vitremer (n = 30). The right molars was always filled by Vitremer. A split-mouth design was used in the present clinical trial. Twenty nine children were involved in the present study and every one had one bilateral identical pair of carious molars except one child that had two identical pairs. This design was performed to enhance the accuracy of the present study.

Procedure: Dental caries was removed from primary molars and was filled with the conventional filling material;Vitremer

Ketac Nano

ACTIVE COMPARATOR

Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano (n=30). The left molars was always restored with Ketac Nano filling material.

Procedure: Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano.

Interventions

Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano.PROCEDURE

Class I carious primary molars were selected. Dental caries was removed and cavities were prepared. The recent nano-filled RMGI filling (Ketac Nano) was used to fill these cavities.

Ketac Nano
Dental caries was removed from primary molars and was filled with the conventional filling material;VitremerPROCEDURE

Class I carious primary molars were selected. Dental caries was removed and cavities were prepared. The conventional RMGI filling (Vitremer) was used to fill these cavities.

Vitremer

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The presence of a bilateral identical pair of primary molars in the same arch containing initial occlusal caries (a minimum of two pits or fissures without any cusp destruction).

You may not qualify if:

  • Handicapped or uncooperative children and children with extensive or rampant caries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, 31111, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Ketac Nano

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Sahar E. Abo-Hamar, DMD, PhD

    Tanta University, Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor (DMD, PhD)

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 20, 2014

Study Start

June 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2013

Last Updated

March 20, 2014

Record last verified: 2014-03

Locations

EG(1)