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Effect of a controlled release system of doxycycline for control of periodontal disease

Effect of a controlled release system of doxycycline for control of periodontal disease: randomized double masking clinical trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-243gf6
Enrollment
Unknown
Registered
2017-10-23
Start date
2014-02-02
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

chronic periodontitis

Interventions

Thirty-three individuals were randomly allocated, by lot, into three independent groups: Group I: 11 individuals and 88 sites. SRP + 10% DOX Gel Group II: 12 individuals and 96 sites. SRP + 10% DOX ge
Drug
Device
Procedure/surgery

Sponsors

Universidade Federal de Minas Gerais
Lead Sponsor
Universidade Federal de Minas Gerais
Collaborator

Eligibility

Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Individuals presenting chronic periodontitis (AAP-1999); individuals with contralateral quadrants containing at least one molar with presence of sites with probing depth 5 mm, clinical insertion level 6 mm and bleeding at probing; over 18 years.

Exclusion criteria

Exclusion criteria: Presence of periapical and pulpal alterations; presence of gingivitis and acute periodontal conditions (abscesses and acute necrotizing periodontitis); presence of candidosis and changes in the mucosa; allergy to the components of gels and periodontal dressings; presence of systemic diseases (cardiovascular, blood dyscrasias, immunodeficiencies, transplanted, diabetes, osteoporosis, nephropathies, hepatopathies); need for antibiotic prophylaxis before periodontal treatment; use of systemic antibiotics, chemotherapeutics of controlled or continuous use and others that may interfere with the inflammatory process or have adverse effects directly in the periodontium in the last 6 months; pregnancy and contraceptive users during the study and during the previous three months or lactation; smokers; surgical or non-surgical periodontal treatment in the last 6 months; treatment with chlorhexidine mouthwash 0.12% or other topical chemical agent in the last 6 months.

Design outcomes

Primary

MeasureTime frame
The parameter clinical attachment level (CAL greater than or equal to 6 mm) was selected as the main variable for the determination of periodontitis and also to determine the size of the sample N;Outcome found 1: Mean difference in gain of clinical attachment level. The level of significance was 5% (p <0.05)

Secondary

MeasureTime frame
Expected outcome 2: periodontal probing depth greater than or equal to 5mm, expected outcome 3: bleeding on probing, present or absent, expected outcome 4: visible plaque index, present or absent, expected outcome 5: interproximal radiographic density, using the fractal analysis technique before and after the treatments. The level of significance was 5% (p <0.05);Outcome found 2: mean difference in reduction of periodontal probing depth, outcome found 3: mean difference in reduction of bleeding on probing, outcome found 4: mean difference in reduction of visible plaque index, outcome found 5: mean difference in gain of interproximal radiographic density, using the fractal analysis technique before and after the treatments. The level of significance was 5% (p <0.05)

Countries

Brazil

Contacts

Public ContactVivianne Trajano

Universidade Federal de Minas Gerais

viviannecunha@hotmail.com+55(31)991545259

Outcome results

None listed

Source: REBEC (via WHO ICTRP)