NCT02994862

Brief Summary

In teeth requiring laminate veneers with amelogenesis imperfecta Will application of galla chinensis before Bonding of laminate veneers with adhesive resin cement provide better survival rate than conventional Bonding method

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
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

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

Study Start

First participant enrolled

December 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

December 8, 2016

Last Update Submit

December 13, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • marginal adaptation assessed by clinical evaluation using dental mirror and probe

    clinical evaluation of marginal adaptation

    1 year

Secondary Outcomes (1)

  • Patient satisfaction assessed using a Questionnaire

    1 Year

Study Arms (2)

Galla Chinnesis

EXPERIMENTAL

new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta

Other: Galla Chinnesis

Conventional Bonding

ACTIVE COMPARATOR

Normal Bonding Method

Other: Conventional Bonding

Interventions

new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta

Galla Chinnesis

Normal Bonding Protocol

Conventional Bonding

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All subjects are required to be:
  • From 18-60 years old, and able to read and sign the informed consent document.
  • Physically and psychologically able to tolerate conventional restorative procedures
  • Have no active periodontal or pulpal diseases, have teeth with good restorations
  • Patients with teeth problems indicated for laminate veneer (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ….)
  • Willing to return for follow-up examinations and evaluation

You may not qualify if:

  • Patients in the growth stage with partially erupted teeth
  • Patient with fractured teeth of more than 50% enamel loss
  • Patients with poor oral hygiene and motivation
  • Pregnant women
  • Psychiatric problems or unrealistic expectations
  • Lack of opposite occluding dentition in the area intended for restoration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cheng L, ten Cate JM. Effect of Galla chinensis on the in vitro remineralization of advanced enamel lesions. Int J Oral Sci. 2010 Mar;2(1):15-20. doi: 10.4248/IJOS10019.

    PMID: 20690414BACKGROUND

MeSH Terms

Conditions

Amelogenesis Imperfecta

Condition Hierarchy (Ancestors)

Developmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Mohammed mohammed, B.D.S

CONTACT

Jylan Elguindy, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
B.D.S

Study Record Dates

First Submitted

December 8, 2016

First Posted

December 16, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 16, 2016

Record last verified: 2016-12