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Evaluation of oral health and saliva biomarkers in patients who undergo Stomach Reduction surgery: a clinical study

Assessment of Caries and Periodontal Disease control, inflammatory markers and oral microbiota after Bariatric surgery: a randomized clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-6b83by6
Enrollment
Unknown
Registered
2024-10-01
Start date
2024-10-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Dental Caries

Interventions

daily use of 0.06 per cent chlorhexidine mouthwash
use of toothpaste with high fluoride concentration (5,000 ppm)
This is a randomized controlled open clinical trial with paralell arms. The study will include 120 adults of both sexes, with severe or morbid obesity with surgical indication (BMI higher or equal 35
topical application of fluoride varnish. All groups will receive the same oral hygiene kits, with the same type of toothbrush and floss for all groups to control confounding factors. With the exceptio
use of dental floss 1 time per day
and educational program (Freitas et al., 2017)
2. Chlorhexidine 0.06 per cent: daily use 2 times per day (Zimmer et al., 2015
James et al., 2017) for 3 months, with the possibility of extension up to 6 months
Toothpaste with high fluoride concentration (5,000 ppm): three brushings per day, twice with toothpaste with 5,000 ppm fluoride (Nordstrom and Birkhed, 2010
Manaa et al., 2014
Fernandez et al., 2017
Vale et al. ., 2022)
Topical application of fluoride varnish: top
D02.078.370.141.100

Sponsors

Universidade Federal de São Paulo (UNIFESP)
Lead Sponsor
Universidade Federal de São Paulo (UNIFESP)
Collaborator

Eligibility

Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Adults. Both sexes. Severe or morbid obesity with surgical indication (body mass index higher or equal 35 kg/m2)

Exclusion criteria

Exclusion criteria: Chronic diseases other than obesity such as cancer, arthritis, asthma, neurological or neurodegenerative diseases. Chronic use of systemic or oral medications that interfere with salivary flow. Smoking. Alcoholism. Use of illicit drugs. Oro-dentofacial diseases. Facial/dental Trauma. Extensive tooth loss. Active carious lesions. Periodontal pockets larger than 3 mm

Design outcomes

Primary

MeasureTime frame
It is expected to evaluate the incidence of caries and periodontal disease using oral clinical indices, comparing the indices at baseline, 3 and 6 months after bariatric surgery and between the four treatment groups

Secondary

MeasureTime frame
Secondarily, we hope to evaluate the impact of therapeutic measures on the oral microbiota and salivary markers at 3 and 6 months after surgery

Countries

Brazil

Contacts

Public ContactPaula Castelo Ferrua

Universidade Federal de São Paulo- UNIFESP

paula.castelo@unifesp.br+55(11)3385-3574

Outcome results

None listed

Source: REBEC (via WHO ICTRP)