Effect of the Use of Xylitol Gum in the Prevention of Caries Lesions in Children Living in Ladakh

NCT04420780 | Withdrawn

• 1 other identifier: CaPreXCh
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Ladakh is a region administered by India, covering an area slightly larger than Croatia; it is part of the larger region of Kashmir and Jammu. Till now, oral health data on population living in Ladakh are not available. The aim of the present preventive project will be to record the caries prevalence of schoolchildren living in Ladakh and to implement a school-based xylitol program using chewing gums in order to reduce caries incidence. Methods: The protocol of the Caries Prevention Xylitol in Children (CaPreXCh) trial is designed as a triple-blind randomized, controlled, parallel-group clinical trial in children aged 5-14 years. The study will be carried out from August 2021 to August 2024 in Zanskar Valley (Ladakh). Participants will be randomly allocated into two groups: subjects who will receive a 100% xylitol chewing gum, and those who will receive a 22% xylitol gum. The subjects will be instructed to chew a total of 6 pellets for 5 min divided into 3 intakes a day (2 in the morning, 2 after the midday meal and 2 in the afternoon) for one school-year. Clinical examination will comprise an oral examination: caries index (ICDAS scores), bleeding on probing recording and evaluation of plaque pH fluctuation after sucrose challenge and will be performed at baseline (t0) and repeated 12 months at the end of the chewing-gum administration period (t1) as interim examination, after 12 months (t2) and 24 months (t3) after the end of the experimental period (chewing gum use). The primary outcome will be the caries increment measured both at enamel and dentinal level. Data analysis will be conducted through Kaplan-Meyer graphs to evaluate caries increment as primary outcome, and the methods will be compared to each other with Cox regression with shared frailty. The net caries increment for initial, moderate and severe caries level, using ICDAS (Δ-initial, Δ-moderate and Δ-severe), will be calculated. Discussion: This is the first clinical trial to assess the effect of chewing gum containing only xylitol as sweeteners for caries prevention. Moreover, the children object of this study is a population with special living conditions.

Conditions

Caries

Keywords

Caries prevention; Xylitol gum; Children

Outcome Measures

Primary Outcomes (2)

• Change from Baseline caries status in enamel (ICDAS index)

  The primary outcome will be the caries increment measured both at surface and tooth level using ICDAS index

  3 years

• Change from Baseline caries status in dentine (ICDAS index)

  The primary outcome will be the caries increment measured both at surface and tooth level using ICDAS index

  3 years

Secondary Outcomes (1)

• Plaque pH measurements in relation to the treatment decision. (PlaquepH strips)

  3 years

Other Outcomes (1)

• Cost- effectiveness analysis

  After 36 months

Study Arms (2)

Xyl Group

EXPERIMENTAL

Children will receive sugar-free gums containing 100% Xylitol as sweetener

Dietary Supplement: Administration of sugar-free gums sugar-free gums containing 100% Xylitol as sweetener

Pol Group

ACTIVE COMPARATOR

Children will receive sugar-free gums containing a polyols mixture plus a low amount of Xylitol (22%).

Dietary Supplement: Administration of sugar-free gums sugar-free gums containing containing a polyols mixture plus a low amount of Xylitol (22%)

Interventions

Administration of sugar-free gums sugar-free gums containing 100% Xylitol as sweetener DIETARY_SUPPLEMENT

The subjects will be instructed to chew a total of 6 pellets for 5 min divided into 3 intakes a day (2 in the morning, 2 after the midday meal and 2 in the afternoon)

Xyl Group

Administration of sugar-free gums sugar-free gums containing containing a polyols mixture plus a low amount of Xylitol (22%) DIETARY_SUPPLEMENT

The subjects will be instructed to chew a total of 6 pellets for 5 min divided into 3 intakes a day (2 in the morning, 2 after the midday meal and 2 in the afternoon)

Pol Group

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Are aged from 5 to 14 years;
• To be in good general health;
• Written informed consent (by the child / parent)

You may not qualify if:

• Children who refuse to participate in the research; parents/guardians who refuse the participation of their children to the trial;
• Children who present systemic conditions or chronic diseases that require differentiated care and follow-up.

Sponsors & Collaborators

• University of Bern: lead
• University of Milan: collaborator
• Università degli Studi di Sassari: collaborator
• WHO Collaborating Center for Epidemiology and Preventive Dentistry: collaborator

Study Sites (1)

Moscou University

Moscow, Russia

Location

Related Publications (1)

• Cagetti MG, Cocco F, Calzavara E, Augello D, Zangpoo P, Campus G. Study protocol for a randomized clinical trial to evaluate the effect of the use of Xylitol gum in the prevention of caries lesions in children living in Ladakh-the Caries Prevention Xylitol in Children (CaPreXCh) trial. Trials. 2021 Dec 4;22(1):871. doi: 10.1186/s13063-021-05828-y.

  PMID: 34863260 DERIVED

MeSH Terms

Interventions

Xylitol; Sweetening Agents

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Flavoring Agents; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Guglielmo Campus

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a triple-blind randomized, controlled, parallel-group clinical trial. Two groups will be compared: subjects who will receive a 100% xylitol chewing gum, and those who will receive a 22% xylitol gum.

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 9, 2020
• Study Start: August 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2024
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The study protocol Summer 2020/2024 Statistical Analysis Plan 2022 Analytic Code at the end of the study 2024

Locations

RU (1)