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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04051255
Other study ID # 088325/2017
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date March 1, 2020

Study information

Verified date August 2019
Source University of Campinas, Brazil
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Treatment of smoker patients with AgP is considered a challenge to periodontists. To date, only one controlled clinical study (De Genaro Modanese et al., 2016) evaluated the effect of full mouth ultrasonic debridment (FMUD) on smokers with aggressive periodontitis. Its results showed significant improvements in clinical parameters (plaque index PI, bleeding on probing- BoP and probing depth-PD), and immunologic (reductions in interleukin 6- IL-6, tumor necrosis factor- α TNF-α levels), although the results were more favorable for non-smoking patients. Antimicrobials associated to mechanical therapy has been extensively studied (Hafajee et al., 2003, Heitz-Mayfield, 2006). The association of Amoxicillin and Metronidazole have had good clinical and microbiological results in randomized clinical trials in the treatment of AgP (Casarin et al., 2012, Sgolastra et al., 2012, Keestra et al., 2015).

Thus, this study investigates clinical, microbiological and immunological influence of smoking in the periodontal debridement associated to Amoxiciclin and Metronidazole of young individuals with pronounced periodontal destruction, compared with non-smokers individuals.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- diagnosis of generalized aggressive periodontitis, according to the American Academy of Periodontology-AAP, 1999;

- presence of at least 15 teeth;

- presence of at least 6 teeth containing 6 deep sites (= 7 mm), which are not located in bifurcation areas and

- present less than 20% of plaque index (PI) and bleeding on probing (BoP).

Exclusion Criteria:

- presence of periapical or pulpar alteration;

- presence of systemic alteration or use of medications (6 months prior to the study) that may influence the response to periodontal treatment;

- pregnant and lactating women;

- performing periodontal treatment including subgingival instrumentation in the 6 weeks preceding the study;

- teeth with bifurcation involvement;

- teeth with marked mobility;

- oral pathology;

- history of allergy to any component of the study, and

- previous periodontal surgery in the region of interest.

Study Design


Intervention

Drug:
full mouth ultrassonic debridement associated to Amoxicilin 500 + Metronidazole 400 mg
The patients were treated by a single-session of periodontal debridement under local anaesthesia during 45 minutes, using an ultrasonic instrument#, using subgengival tips* and irrigation with sterile saline solution, by the same operator (MGC, Paulista University, São Paulo, Brazil). After the debridement, all patients was prescribed with Amoxicillin 500 mg and Metronidazole 400 mg, every 8 hours, for 10 days (Casarin et al., 2012). Subjects were extensively informed about the intake of the prescribed medication. Subjects were clinically and microbiologically monitored at baseline (before therapy) and at 3 and 6 months post-therapy. During the monitored sessions, oral hygiene was evaluated and home care instructions were re-emphasized. Additionally, all subjects were recalled monthly for oral hygiene instructions.

Locations

Country Name City State
Brazil University of Campinas, UNICAMP Piracicaba Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical attachment level (CAL) changes at 6 months Indicates the distance between the base of the gingival pocket and the cemento-enamel junction, detected with a periodontal probe of 15 mm. 6 months
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