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Investigating Oral Microbiome Profiles in Children with Cleft Lip and Palate with Different Degrees of Caries

Investigating Oral Microbiome Profiles in Children with Cleft Lip and Palate with Different Degrees of Caries

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500095775
Enrollment
Unknown
Registered
2025-01-13
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft lip and palate and cleft alveolar

Interventions

Cleft lip and palate (high caries) Group A :None
Cleft lip and palate (low caries) Group B:None
Non-cleft lip and palate (high caries) Group A:None
Non-cleft lip and palate (low caries) Group B:None

Sponsors

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Test Group A: 1) Patients with cleft lip and palate (including cleft lip, cleft palate, cleft lip and palate, patients with cleft palate and cleft lip and palate with or without alveolar fissure, and included before or after bone grafting); 2) S(DMFS+dmfs) index: S>8; 3) Age 6-12 years old (including 6 years old and 12 years old), mixed dentition stage, good general health, psychomotor development in line with age; 4) Have not taken chronic medication or antibiotics in the past 3 months; 5) No salivary gland disease, no other oral diseases (such as periodontitis, mucosal disease); 6) Children who can cooperate with oral examination and saliva and plaque collection; 7) Informed consent of subjects and their parents or guardians. 2. Test Group B: 1) Patients with cleft lip and palate (including cleft lip, cleft palate, cleft lip and palate, patients with cleft palate and cleft lip and palate with or without alveolar fissure, and included before or after bone grafting); 2) S(DMFS+dmfs) index: 08 3) Age 6-12 years old (including 6 years old and 12 years old), mixed dentition stage, good general health, psychomotor development in line with age; 4) Have not taken chronic medication or antibiotics in the past 3 months; 5) No salivary gland disease, no other oral diseases (such as periodontitis, mucosal disease); 6) Children who can cooperate with oral examination and saliva and plaque collection; Informed consent of subjects and their parents or guardians. 4. Control group B: 1) Newly diagnosed patients in the Department of Endodontics, Preventive Dentistry, Pediatric Stomatology and Orthodontics of Shanghai Ninth People's Hospital; 2) S(DMFS+dmfs) index: 0<S<=8 3) Age 6-12 years old (including 6 years old and 12 years old), mixed dentition stage, good general health, psychomotor development in line with age; 4) Have not taken chronic medication or antibiotics in the past 3 months; 5) No salivary gland disease, no other oral diseases (such as periodontitis, mucosal disease); 6) Children who can cooperate with oral examination and saliva and plaque collection; 7) Informed consent of subjects and their parents or guardians.

Exclusion criteria

Exclusion criteria: 1) Systemic diseases (such as heart disease, diabetes, hypertension, etc.); 2) Developmental diseases, such as rickets, hyperpituitarism, anterior pituitary insufficiency, cretinism, acromegaly, Turner syndrome, etc.; 3) Salivary gland disease and other oral diseases, such as periodontitis and mucosal disease; 4) Taking chronic medication or antibiotics in the past 3 months; 5) Children who have undergone professional fluoride application in the past 3 months; 6) Children who are unable to cooperate with oral examination and saliva and plaque collection; 7) Refusal to sign informed consent or refusal to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
DMFS;

Secondary

MeasureTime frame
plaque index,PLI;Gingival index,GI;

Countries

China

Contacts

Public ContactChen Zhenqi

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

orthochen@yeah.net+86 21 23271699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026