Impact of Ultra-Processed Food Intake on Gingival Tissue Health

NCT06411535 | Completed

• 1 other identifier: UPF001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The shift towards consuming more industrialized food products, particularly ultra-processed foods, has been linked to a rise in non-communicable diseases globally. These products are energy-dense, high in unhealthy components, and often lead to overconsumption due to their palatability and convenience. Studies suggest a connection between ultra-processed food consumption and various health issues, including obesity and cardiovascular diseases. The present study is designed as a single-center, double-blind, parallel-arm randomized clinical trial. This study aims to investigate the impact of ultra-processed food consumption on gingival health and to evaluate the potential benefits of dietary counseling and reduced ultra-processed food intake on gingival inflammation over a 4-month period.

Conditions

Gingivitis; Ultra-processed Food; Prevention

Outcome Measures

Primary Outcomes (1)

• Change in Full Mouth Bleeding Score (FMBS)

  Evaluate the effect of Nutritional Counseling on gingival bleeding

  Full Mouth Bleeding Score (FMBS) collected six sites per tooth, full mouth, will be recorded by a calibrated and blinded examiner at the baseline visit (T0), at two months (T2) and follwing active treatment, at 4 months (T4)

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patients answer the OHIP 14 and the Food Frequency Questionnaires, and are classified according to the NOVA classification. A full-mouth periodontal chart is performed. After 8 weeks, Questionnaires are re-administered. A full-mouth periodontal chart is performed, along with a session of full-mouth ultrasonic debridement. After 16 weeks from baseline, administration of the OHIP 14 and the FFQ is repeated. Clinical variables are re-evaluated.

Other: Full-mouth ultrasonic debridement

Nutritional Counseling Group

EXPERIMENTAL

Patients answer the OHIP 14 and a Food Frequency Questionnaires, and are classified according to the NOVA classification. A full-mouth periodontal chart is perfomed. Patients receive a nutritional counseling on the significance of reducing ultra-processed food intake. Patients receive weekly motivational emails, as part of the dietary counseling. After 8 weeks, Questionnaires are readministered. A full-mouth periodontal chart is performed, along with a session of full-mouth ultrasonic debridement. Nutritional counseling is reinforced. Patients receive weekly motivational emails, as part of the dietary counseling. After 16 weeks from baseline, administration of the OHIP 14 and the FFQ is repeated. Clinical variables are re-evaluated.

Behavioral: Full-mouth ultrasonic debridement plus Nutritional counseling

Interventions

Full-mouth ultrasonic debridement plus Nutritional counseling BEHAVIORAL

After diagnosis of gingivitis, patients will receive a nutritional counseling focused on ultra-processed foods entails educating individuals about the nutritional content and potential health implications of highly processed food products. They will undergo a session of full-mouth ultrasonic debridement and reinforcment of dietary counseling. Between consecutive time points, patients will receive motivational emails.

Nutritional Counseling Group

Full-mouth ultrasonic debridement OTHER

After diagnosis of gingivitis, patients will receive a session of full mouth ultrasonic debridement

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age.
• Non-smokers (never smokers or former smokers for at least 6 months).
• Presence of FMBS \>= 10%
• No interproximal attachment loss of ≥3 mm in ≥2 non-adjacent teeth

You may not qualify if:

• Carious lesions and/or inadequate restorations.
• Subjects currently undergoing orthodontic therapy or wearing occlusal bite guards.
• Subjects suffering any systemic disease or condition which may affect the response of gingival tissues or the ability to perform adequate plaque control (pregnancy, diabetes, quantitative and/or qualitative polymorphonuclear neutrophils defects, other immune system disorders, etc.)
• Subjects taking medications that could interfere with the gingival tissues response (i.e. anti-inflammatory agents, diphenylhydantoin, calcium channel blockers, cyclosporin A, immunostimulants/immunomodulators)

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

AOUS

Siena, 53100, Italy

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Nicola Discepoli, DDS MSc PhD

  Department of Medical Biotechnologies, University of Siena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 13, 2024
• Study Start: May 21, 2024
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

IT (1)