Influence of Smoking on Clinical, Microbiological and Immunologic Parameters in Patients With Aggressive Periodontitis.

NCT ID: NCT04051255

Last Updated: 2019-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2020-03-01

Brief 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.

Conditions

Periodontal Diseases; Aggressive Periodontitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Smokers aggressive periodontits

The patients were treated by a single-session of periodontal debridement under local anaesthesia during 45 minutes, using an ultrasonic instrument#, using subgingival tips\* and irrigation with sterile saline solution, by the same operator (MGC, Paulista University, São Paulo, Brazil). After the debridement, all patients has 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.

Group Type: EXPERIMENTAL

full mouth ultrassonic debridement associated to Amoxicilin 500 + Metronidazole 400 mg

Intervention Type: DRUG

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.

Non-smokers aggressive periodontits

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.

Group Type: EXPERIMENTAL

full mouth ultrassonic debridement associated to Amoxicilin 500 + Metronidazole 400 mg

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Campinas, Brazil

OTHER

Sponsor Role: lead

Responsible Party

Renato Casarin

Professor of Periodontics in Piracicaba Dental School-FOP/UNICAMP

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Campinas, UNICAMP

Piracicaba, São Paulo, Brazil

Countries

Brazil

Other Identifiers

088325/2017

Identifier Type: -

Identifier Source: org_study_id