NCT03966378

Brief Summary

Assess the effectiveness of applying grape seed extract (GSE) gel versus casein phosphopeptide-amorphous calcium phosphate (MI) paste on remineralization of white spot lesion (WSLs) in post orthodontic patients.

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
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

May 22, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

October 3, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2020

Completed
Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

6 months

First QC Date

May 22, 2019

Last Update Submit

May 25, 2019

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • Quantitative changes of white spot lesions

    changes in fluorescence of white spot lesions will be evaluated after reminerlization by using diagnodent device by score (0-20).

    evaluation of tooth surface changes at baseline and at 4, 12, and 24 weeks after starting treatment .

Study Arms (2)

Grape seeds extract

EXPERIMENTAL

Every week the grape seeds extract (gel) put into the tray and apply it to the upper teeth of the participant.

Other: Grape seeds extract

Casein-phosphopeptide/amorphous-calcium phosphate

ACTIVE COMPARATOR

CPP-ACP paste apply to the teeth twice daily.

Other: Casein-phosphopeptide/amorphous-calcium phosphate

Interventions

Grape seeds extractOTHER

Grape seeds extract powder

Grape seeds extract
Casein-phosphopeptide/amorphous-calcium phosphateOTHER

CPP-ACP paste

Casein-phosphopeptide/amorphous-calcium phosphate

Eligibility Criteria

Age13 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Presence of at least two WSLs on the labial surfaces of six maxillary anterior teeth that were not present before orthodontic therapy.

You may not qualify if:

  • Severe or active periodontal disease.
  • Patients had received therapeutic irradiation to the head and neck region.
  • Patients had participated in a clinical trial within 6 months before commencement of this trial.
  • Patients unable to return for recall appointments
  • Presence of abnormal oral, medical, or mental condition (including any milk-related allergies or any medical condition involving kidneys or salivary glands).
  • Presence of restorations or cavities in any anterior teeth or enamel hypoplasia, dental fluorosis, or intrinsic and extrinsic pigmentation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Caries

Interventions

amorphous calcium phosphate

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

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
pricipal investigator

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 29, 2019

Study Start

October 3, 2019

Primary Completion

April 6, 2020

Study Completion

May 10, 2020

Last Updated

May 29, 2019

Record last verified: 2019-05