NCT06976385

Brief Summary

The current study aimed to evaluate the color change potential of wheat grass and white tea on post orthodontic white spot lesions (WSLs). Materials and Methods: A total of 12 patients were divided into two main groups A1 and A2 according to type of treatment agent (n=6). The A1 group used 10% white tea solution while the A2 group used 10% wheat grass solution. Shade evaluation was conducted using VITA Easyshade V spectrophotometer. Baseline L a b values of WSLs were detected right after orthodontic bracket removal. Patients were requested to rinse with the treatment agent for 1 minute, twice per day. The mean L,a,b values were recorded after 1 month and after 3 months . ΔE values were calculated between baseline, 1 month and 3 months after the treatment agent application and subjected to statistical analysis using one way ANOVA with p\>0.05. Also, Standardized photographs were taken at baseline, after 1 and 3 months. Each WSL was photographed twice with the 1st photograph taken of wet teeth and the 2nd one after prolonged air-drying in order to perform ICDAS II scoring.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 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

October 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

May 9, 2025

Last Update Submit

May 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • ΔE values were calculated

    The mean L,a,b values were recorded . ΔE values were calculated

    after 1 month and after 3 months

Study Arms (2)

White tea

EXPERIMENTAL

Participants prepared white tea mouth rinse to rinse thoroughly . At each rinsing, 10 mL of the solution was swished around the mouth for about 60 s and then spited This procedure was performed twice per day for 1 , and 3 months

Dietary Supplement: White tea

Wheat grass solution

EXPERIMENTAL

Participants prepared wheat grass solution mouth rinse to rinse thoroughly . At each rinsing, 10 mL of the solution was swished around the mouth for about 60 s and then spited This procedure was performed twice per day for 1 , and 3 months

Dietary Supplement: Wheat grass solution

Interventions

White teaDIETARY_SUPPLEMENT

White tea mouth rinse applied topically twice daily.

White tea
Wheat grass solutionDIETARY_SUPPLEMENT

wheat grass solution mouth rinse applied topically twice daily.

Wheat grass solution

Eligibility Criteria

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

You may qualify if:

  • Age range between 15-18 years.
  • Good oral hygiene
  • Obvious area of WSL was found around the fixed orthodontic brackets.
  • Included teeth should be free of any restorations

You may not qualify if:

  • \- : 1. Cavitated enamel surface. 2. Presence of any restorations including the labial surface of the involved teeth.
  • \. Presence of any environmental or developmental enamel defect such as enamel hypoplasia, fluorosis, stains, and trauma sites on teeth before orthodontic treatment. 4. Allergy to tea and/or wheat

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Azhar University

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of conservative dentistry

Study Record Dates

First Submitted

May 9, 2025

First Posted

May 16, 2025

Study Start

October 15, 2023

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations