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

Influence of Smoking on Clinical, Microbiological and Immunologic Parameters in Patients With Aggressive Periodontitis Treated With Non-surgical Mechanical Therapy Associated With Systemic Antibiotic Therapy.

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.

Study Overview

• Status: Unknown
• Conditions: Periodontal Diseases; Aggressive Periodontitis
• Intervention / Treatment: Drug: full mouth ultrassonic debridement associated to Amoxicilin 500 + Metronidazole 400 mg

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Piracicaba, Sao Paulo, Brazil, 13414-903
      • University of Campinas, UNICAMP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Campinas, Brazil

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 12, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stomatognathic Diseases; Mouth Diseases; Aggression; Periodontitis; Periodontal Diseases; Aggressive Periodontitis; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: 088325/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No