CClinicalTrials.gg
Status unknownNCT03966378Updated May 29, 2019

Reminerlization Potential of GSE Gel versusCPP-ACP in Carious White Spot Lesions in Post Orthodontic Patients

An interventional study of Grape seeds extract and Casein-phosphopeptide/amorphous-calcium phosphate in Dental Caries, sponsored by Cairo University. Status unknown. Open to participants aged 13 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-29.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
13 Years to 35 Years
Sex
All
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Study 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.

Read the detailed description

The development of WSLs is a challenging problem in the track of orthodontic treatment. Especially in patients wearing fixed orthodontic appliances, plaque accumulation increases around brackets and bands and the pH on dental surfaces becomes acidic.

These early lesions are willing to remineralization, arrest, reharden and revert to healthy enamel condition through a remineralization process involving the diffusion of minerals into the defective tooth structure. For this purpose various remineralizing agents such as casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and grape seed extract (GSE) have been used.

This research is conducted for early intervention and treatment of the white spot lesions by non-invasive method.

02

Conditions studied

  • Dental Caries

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03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's planned enrollment of 24 is below the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
13 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Grape seeds extract

    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

  • Active comparator
    Casein-phosphopeptide/amorphous-calcium phosphate

    CPP-ACP paste apply to the teeth twice daily.

    Other: Casein-phosphopeptide/amorphous-calcium phosphate

Interventions

  • OtherGrape seeds extract

    Grape seeds extract powder

  • OtherCasein-phosphopeptide/amorphous-calcium phosphate

    CPP-ACP paste

06

What researchers measure

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).

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

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03966378
Lead sponsor
Cairo University
Responsible party
Aseel Saleh Omeran (pricipal investigator, Cairo University) — Principal investigator
First posted
May 29, 2019
Start date
Oct 3, 2019 (estimated)
Primary completion
Apr 6, 2020 (estimated)
Completion
May 10, 2020 (estimated)
Last update
May 29, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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