NCT07755111

Brief Summary

This study aims to evaluate the effects of pranayamic breathing techniques and tongue exercises on oral microbiota in children aged 7-12 years. Children will be grouped according to their breathing patterns (mouth or nasal breathing), and a structured breathing and tongue exercise program will be applied. Saliva samples will be collected before and after the intervention to analyze changes in oral microbiota. The study will include approximately 80 participants and is expected to last for 6 months. There are no anticipated risks for participants. The findings of this study may contribute to a better understanding of the relationship between breathing patterns, oral exercises, and oral health in children.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress52%
Mar 2026Dec 2026

Study Start

First participant enrolled

March 28, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

August 10, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 19, 2026

Last Update Submit

August 7, 2026

Conditions

Keywords

Oral MicrobiotaPranayamic Breathinghumming exerciseMouth BreathingTongue Exercises

Outcome Measures

Primary Outcomes (1)

  • Change in oral microbiota alpha diversity as measured by the Shannon diversity index from 16S rRNA gene sequencing of saliva samples

    This outcome evaluates the effect of the intervention (pranayamic breathing exercises, tongue exercises, and tongue-cleaning practice) on the diversity of the oral microbiota. Alpha diversity will be assessed from saliva samples using 16S rRNA gene sequencing and quantified using the Shannon diversity index. The mean Shannon index at baseline will be compared with the value after the 8-week intervention, and the change from baseline will be reported.

    8 weeks

Secondary Outcomes (1)

  • Salivary Nitric Oxide Levels

    8 weeks

Study Arms (2)

Mouth Breathing Group

EXPERIMENTAL

Participants with mouth breathing habits will be included in this group. A structured program consisting of pranayamic breathing techniques, tongue exercises, and, in selected subgroups, tongue cleaning will be applied. Saliva samples will be collected before and after the intervention to evaluate changes in oral microbiota.

Behavioral: Pranayamic Breathing and Tongue Exercises

Nasal Breathing Group

EXPERIMENTAL

Participants with nasal breathing habits will be included in this group. A structured program consisting of pranayamic breathing techniques, tongue exercises, and, in selected subgroups, tongue cleaning will be applied. Saliva samples will be collected before and after the intervention to evaluate changes in oral microbiota.

Behavioral: Pranayamic Breathing and Tongue Exercises

Interventions

Participants will perform a structured program including pranayamic breathing techniques and tongue exercises, and, in selected subgroups, tongue cleaning. The program will be applied regularly over the study period, and saliva samples will be collected before and after the intervention to assess changes in oral microbiota.

Mouth Breathing GroupNasal Breathing Group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 7-12 years with either mouth breathing or nasal breathing patterns
  • Willingness of both the child and their legal guardian to participate in the study
  • Children who are cooperative and able to comply with the exercise protocol

You may not qualify if:

  • Refusal of the child or legal guardian to participate in the study
  • Presence of active dental caries or periodontal disease
  • Presence of any systemic disease or regular medication use
  • Use of orthodontic appliances
  • Use of antibiotics or probiotics within the last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dentistun Oral and Dental Health Center, Istanbul Health and Technology University

Istanbul, Bahcelievler, 34180, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Mouth Breathing

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Bugra OZEN, DDS, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor responsible for microbiota analysis will be blinded to group allocation. Saliva samples will be coded and anonymized to prevent identification of participants' group assignments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 19, 2026

First Posted

August 10, 2026

Study Start

March 28, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

August 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations