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IRCT20260417069084N1 IRCT 2026-04-22 Esfahan University of Medical Sciences Evaluation of Green Tea Extract and CPP-ACP effect on white spots Evaluation of Green Tea Extract and Casein Phosphopeptide- Amorphous Calcium Phosphate (CPP-ACP) effect on white spot recovery in retention phase of fixed orthodontic treatment: A Triple-Blind Randomized Clinical Trial 2026-05-21 anticipated 72 Complete https://irct.ir/trial/89502 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study for each ingredient will be conducted in a split‑mouth design. Considering the differences in individuals’ brushing patterns on the dominant and non‑dominant side (depending on right‑ or left‑handedness), and the potential differences in oral hygiene accuracy and fluoride exposure between the two sides of the jaw, the number of teeth receiving the intervention on the dominant side will also be kept equal. Therefore, Group 1 will include 36 teeth (18 pairs), in which 18 teeth on the dominant side (according to right‑ or left‑handedness) will receive green tea extract and the contralateral teeth will receive placebo. Another 18 teeth on the non‑dominant side will receive green tea extract and the opposite teeth will receive placebo. Group 2 will include 36 teeth (18 pairs), in which 18 teeth on the dominant side will receive CPP‑ACP paste and the contralateral teeth will receive placebo. Another 18 teeth on the non‑dominant side will receive CPP‑ACP paste and the opposite teeth will receive placebo. Randomization of sample allocation will be performed using simple randomization based on a random number table, Blinding description: The patient is given two syringes, one containing the intervention material (CPP-ACP or green tea) and the other containing a placebo. The patient is unaware of which syringe contains the active material or the placebo. During the evaluation; after one and two months, the assessment is performed by a second investigator who is blinded to the side of the intervention. During data analysis as well, the statistical analyst will have no information regarding the type of intervention used in the patients’ mouths or the side on which it was applied. Therefore, the study will be triple-blind, and the patient, the intervention provider, and the statistical analyst will all be unaware of the type of material used for application, delivery to the patients, or the assessment and analysis of remineralization. 3 White Spot Lesions. Intervention 1: Intervention group: Green Tea Extract. Intervention 2: Intervention group: Casein Phosphopeptide-Amorphous Calcium Phosphate. Intervention 3: Control group: Placebo. Yes - There is a plan to make this available What will be shared: In addition to the main information containing the primary outcome, other necessary information, such as demographic data, the level of participant cooperation and... can also be published if necessary, provided that no personally identifiable information is disclosed. When: The access period begins 3 months after the publication of the results. To whom: Provided that all participants’ rights in the study are fully respected and their contact or identifying information is not disclosed, it is possible to share their non-private data with all academic or non-academic researchers, as well as pharmaceutical development companies. Conditions: The data are shared solely to make the study more transparent and to allow their use for research purposes as well as for development and production activities in pharmaceutical companies and similar organizations. Where to obtain: For this purpose, requests should be sent to the email address of the corresponding author. The corresponding author’s email address is: parnianrdi2@gmail.com How to obtain: The applicant must clearly state the reasons for requesting additional information and acknowledge that only non‑private participant data can be provided. After submitting the request, the applicant should allow up to two weeks for the required information to be delivered. Comments:
public Amin Ansarinia
Dentistry School, Isfahan University of Medical Sciences, Hezar Jarib St.
Isfehan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5535 ansarinia@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Amin Ansarinia
Dentistry School, Isfahan University of Medical Sciences, Hezar Jarib St.
Isfehan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5535 ansarinia@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) The patient is aged between 15 and 30 years Initiation of the retention phase following fixed orthodontic treatment with the prescription of an Essix retainer for at least one arch Presence of at least one and at most five inactive enamel white‑spot lesions with a maximum size of 4 mm and a DIAGNOdent score between 10 and 20 located on the labial or lingual surfaces of corresponding teeth on both sides of the same arch The individual must have the willingness and mental/physical ability to maintain proper oral hygiene and cooperate throughout the study 15 years 30 years Both Systemic diseases affecting oral tissues or salivary quality Severe tooth rotation prior to orthodontic treatment Gingival hyperplasia or severe inflammation Tobacco use or use of anti‑caries products The patient with DMFT score higher than 8 (High Risk) Treatment - Drugs Treatment - Drugs Placebo Intervention group: Green Tea Extract Intervention group: Casein Phosphopeptide-Amorphous Calcium Phosphate Control group: Placebo WSLs Remineralization Score Measured By DIAGNOdent Pen. Timepoint: Baseline, one month, two months. Method of measurement: DIAGNOdent Pen. Esfahan University of Medical Sciences Approved 2026-04-11 Ethics committee of Isfahan University of Medical Sciences School of Dentistry, Isfahan University of Medical Sciences and Health Services, Hezarjerib Street Isfahan Isfehan Iran (Islamic Republic of)