NCT03168620

Brief Summary

Aim: To evaluate whether glass ionomer interim therapeutic restoration (ITR) in asymptomatic teeth with deep cavities can help in determining the pulp status. Methodology: 146 mandibular molars with deep carious lesion having positive response to pulp sensitivity were randomly allocated to two study groups (75-ITR, 71- NON-ITR group). In the first group after partial caries removal(PCR), interim therapeutic restoration of glass ionomer cement (GIC) Ketac molar was placed for one month before definitive adhesive restoration. In NON-ITR group, cavity preparation was similar to ITR group, but definitive restoration was done in the same visit. Two examiners evaluated the clinical and radiographic outcomes for 18 months. Success was defined as absence of signs and symptoms of irreversible pulpitis and absence of periapical alterations.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

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

May 20, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

May 23, 2017

Last Update Submit

May 25, 2017

Conditions

Pulpitis

Outcome Measures

Primary Outcomes (2)

  • clinical success

    Success was defined as absence of signs and symptoms of irreversible pulpitis (spontaneous pain, fistula and swelling), positive response to pulp sensibility tests.

    18 months

  • radiographic success

    Absence of periapical alterations (radiolucency at furcal or periapical region, calcification). Pretreatment pulpal diagnosis was considered successful when teeth treated with or without ITR were diagnosed as vital and radiographic signs and symptoms of failure developed.

    18 months

Study Arms (2)

ITR group

ACTIVE COMPARATOR

In ITR group after partial caries removal(PCR), interim therapeutic restoration of glass ionomer cement (GIC) Ketac molar was placed for one month before definitive adhesive restoration

Procedure: Restoration

Non ITR group

ACTIVE COMPARATOR

In NON-ITR group, cavity preparation was similar to ITR group, but definitive restoration was done in the same visit

Procedure: Restoration

Interventions

RestorationPROCEDURE
Also known as: Filling
ITR groupNon ITR group

Eligibility Criteria

Age15 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • mature permanent mandibular molars having deep carious lesions involving half or more of the dentine detected by radiographic examination,
  • pulp sensibility confirmed using the electric pulp test (Digitest D626D; Parkell Electronics, New York, NY) and the cold test (Endo frost, Coltene, Whaledent),
  • absence of apical and furcal radiolucency determined by radiographic examination,
  • absence of clinical symptoms of irreversible symptoms, fistula, swelling and abnormal tooth mobility.
  • Clinical diagnosis of vital pulp was made on the basis of radiographic and clinical examination and the pulp sensibility tests.

You may not qualify if:

  • had negative response to vitality tests before or after ITR,
  • diabetic, immunocompromised,
  • pregnant,
  • had a positive history of antibiotic use in past one month or required antibiotic prophylaxis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Design

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

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 30, 2017

Study Start

May 20, 2015

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share