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

Primary Purpose

Periodontal Diseases, Aggressive Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
full mouth ultrassonic debridement associated to Amoxicilin 500 + Metronidazole 400 mg
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Campinas, UNICAMP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Smokers aggressive periodontits

Non-smokers aggressive periodontits

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 7, 2019
Last Updated
August 8, 2019
Sponsor
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT04051255
Brief Title
Influence of Smoking on Clinical, Microbiological and Immunologic Parameters in Patients With Aggressive Periodontitis.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Aggressive Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smokers aggressive periodontits
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-smokers aggressive periodontits
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
full mouth ultrassonic debridement associated to Amoxicilin 500 + Metronidazole 400 mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical attachment level (CAL) changes at 6 months
Description
Indicates the distance between the base of the gingival pocket and the cemento-enamel junction, detected with a periodontal probe of 15 mm.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of Campinas, UNICAMP
City
Piracicaba
State/Province
Sao Paulo
ZIP/Postal Code
13414-903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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