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Full-mouth Periodontal Debridement and Metronidazole Gel in Patients With Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status

Completed

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Full-mouth periodontal debridement

Metronidazole tablet

placebo gel

Metronidazole benzoate gel

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring chronic periodontitis, metronidazole

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

diagnosis of chronic periodontitis
presence of at least 6 periodontal pockets with a clinical attachment loss of ≥5 mm
bleeding on probing (BOP)
radiographic bone loss
probing pocket depth higher or equal to 5 mm in at least six teeth
at least 20 teeth in mouth (third molars excluded)
an established smoking habit (at least 10 cigarettes per day for the past 4 years)

Exclusion Criteria:

periapical alterations in qualifying teeth
medical disorders requiring prophylactic antibiotic therapy or interfering with the treatment
periodontal treatment in the past 6 months
use of drugs known to affect periodontal status (antibiotic, anti-inflammatory, anticonvulsant, immunosuppressant and calcium channel blocker) within the past 6 months
orthodontic therapy
pregnancy and lactation
allergy to metronidazole
any systemic diseases (e.g.: diabetes and immunological disorders)

Sites / Locations

Piracicaba Dental School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Full-mouth PD+placebo gel

Full-mouth PD+Metronidazole tablet

Full-mouth PD+Metronidazole benzoate gel

Arm Description

Full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour + trays with 3 g of placebo gel (semi-solid suspension containing carbopol), overnight, during seven days.

Full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour + single oral dose of 750 mg tablets/day at night, during seven days.

Full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour + trays with 3 g of 15% Mtz benzoate gel (semi-solid suspension containing carbopol), overnight, during seven days.

Outcomes

Primary Outcome Measures

Changes in PPD

Probing pocket depth (PPD) measured from the bottom of the periodontal pocket to the gingival margin were considering four tooth surfaces: mesial, distal, buccal and lingual. Measurements were performed by a calibrated clinician.

Secondary Outcome Measures

Changes in microbiological biofilm composition

Subgingival biofilm samples were collected from five pockets of each patient, present 5-6mm at the baseline period in a single root tooth.

Changes in VPI

Visible plaque index (VPI) measured on four tooth surfaces: mesial, distal, buccal and lingual. Measurements were performed by a calibrated clinician.

Changes in GBI

Gingival bleeding index (GBI) measured on four tooth surfaces: mesial, distal, buccal and lingual. Measurements were performed by a calibrated clinician.

Changes in RAL

Relative attachment level (RAL) measured from the stent to the bottom of periodontal pocket. Measurements were performed by a calibrated clinician.

Full Information

NCT ID

NCT01938183

First Posted

August 30, 2013

Last Updated

September 4, 2013

Sponsor

University of Campinas, Brazil

Collaborators

Faculty Sao Leopoldo Mandic Campinas

1. Study Identification

Unique Protocol Identification Number

NCT01938183

Brief Title

Full-mouth Periodontal Debridement and Metronidazole Gel in Patients With Chronic Periodontitis

Official Title

Full-mouth Periodontal Debridement With or Without Adjunctive Metronidazole Gel in Smoking Patients With Chronic Periodontitis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Campinas, Brazil

Collaborators

Faculty Sao Leopoldo Mandic Campinas

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Hypothesis: metronidazole gel applied topically after periodontal debridement in smokers volunteers could improve clinical parameters when compared to metronidazole tablets + periodontal debridement. Method: 30 smokers with chronic periodontitis were randomly assigned into 3 groups: periodontal debridement combined with 3 g placebo gel; periodontal debridement combined with daily topical application of 3 g metronidazole benzoate gel (15%); and periodontal debridement combined with a daily single dose of 750 mg metronidazole. Clinical parameters evaluated were visible plaque, gingival bleeding, probing pocket depth and relative attachment level.

Detailed Description

Background. The benefit of adjunctive metronidazole on periodontal procedure in smokers with chronic periodontitis (CP) is uncertain. The authors compared the effect of metronidazole (Mtz) on full-mouth periodontal debridement (PD= 1 hour of ultrasonic calculus/plaque removal) in smokers with CP. Methods. This pilot study involved 30 Individuals (having at least six teeth with a clinical attachment loss of ≥ 5 mm and probing pocket depth (PPD) of ≥5 mm) that were randomly assigned into three groups (n=10): 1) PD plus 3 g of placebo gel daily topical application 2) PD plus daily topical application of 3 g of 15% Mtz benzoate gel; and 3) PD plus a daily single dose of 750 mg Mtz (Flagyl®). Clinical parameters visible plaque index (VPI), gingival bleeding index (GBI), relative attachment level (RAL) and PPD; and the quantitative analysis (real-time PCR) of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis and Tannerella forsythia were assessed baseline, 1, 3 and 6 months after PD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Periodontitis

Keywords

chronic periodontitis, metronidazole

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Full-mouth PD+placebo gel

Arm Type

Placebo Comparator

Arm Description

Arm Title

Full-mouth PD+Metronidazole tablet

Arm Type

Active Comparator

Arm Description

Full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour + single oral dose of 750 mg tablets/day at night, during seven days.

Arm Title

Full-mouth PD+Metronidazole benzoate gel

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Full-mouth periodontal debridement

Other Intervention Name(s)

Intervention Description

full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour

Intervention Type

Drug

Intervention Name(s)

Metronidazole tablet

Other Intervention Name(s)

MTZ tablet

Intervention Description

750 mg metronidazole tablets

Intervention Type

Drug

Intervention Name(s)

placebo gel

Intervention Description

semi-solid suspension containing carbopol

Intervention Type

Drug

Intervention Name(s)

Metronidazole benzoate gel

Other Intervention Name(s)

MTZ GEL

Intervention Description

15% Mtz benzoate in semi-solid suspension containing carbopol (gel)

Primary Outcome Measure Information:

Title

Changes in PPD

Description

Time Frame

Change from baseline to 6 months

Secondary Outcome Measure Information:

Title

Changes in microbiological biofilm composition

Description

Subgingival biofilm samples were collected from five pockets of each patient, present 5-6mm at the baseline period in a single root tooth.

Time Frame

Change from baseline to 6 months

Title

Changes in VPI

Description

Visible plaque index (VPI) measured on four tooth surfaces: mesial, distal, buccal and lingual. Measurements were performed by a calibrated clinician.

Time Frame

Change from baseline to 6 months

Title

Changes in GBI

Description

Gingival bleeding index (GBI) measured on four tooth surfaces: mesial, distal, buccal and lingual. Measurements were performed by a calibrated clinician.

Time Frame

Change from baseline to 6 months

Title

Changes in RAL

Description

Relative attachment level (RAL) measured from the stent to the bottom of periodontal pocket. Measurements were performed by a calibrated clinician.

Time Frame

Change from baseline to 6 months

Other Pre-specified Outcome Measures:

Title

Drug use compliance

Description

Drug use compliance was measured by salivary drug concentration on the eighth day after periodontal debridement.

Time Frame

After 8 days of periodontal treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: diagnosis of chronic periodontitis presence of at least 6 periodontal pockets with a clinical attachment loss of ≥5 mm bleeding on probing (BOP) radiographic bone loss probing pocket depth higher or equal to 5 mm in at least six teeth at least 20 teeth in mouth (third molars excluded) an established smoking habit (at least 10 cigarettes per day for the past 4 years) Exclusion Criteria: periapical alterations in qualifying teeth medical disorders requiring prophylactic antibiotic therapy or interfering with the treatment periodontal treatment in the past 6 months use of drugs known to affect periodontal status (antibiotic, anti-inflammatory, anticonvulsant, immunosuppressant and calcium channel blocker) within the past 6 months orthodontic therapy pregnancy and lactation allergy to metronidazole any systemic diseases (e.g.: diabetes and immunological disorders)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cristiane C Bergamaschi, PhD

Organizational Affiliation

University of Campinas, Brazil

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Francisco C Groppo, PhD

Organizational Affiliation

University of Campinas, Brazil

Official's Role

Study Chair

Facility Information:

Facility Name

Piracicaba Dental School

City

Piracicaba

State/Province

ZIP/Postal Code

13414903

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

19017035

Citation

Lorentz TC, Cota LO, Cortelli JR, Vargas AM, Costa FO. Prospective study of complier individuals under periodontal maintenance therapy: analysis of clinical periodontal parameters, risk predictors and the progression of periodontitis. J Clin Periodontol. 2009 Jan;36(1):58-67. doi: 10.1111/j.1600-051X.2008.01342.x. Epub 2008 Oct 30.

Results Reference

background

PubMed Identifier

15811059

Citation

Carvalho LH, D'Avila GB, Leao A, Goncalves C, Haffajee AD, Socransky SS, Feres M. Scaling and root planing, systemic metronidazole and professional plaque removal in the treatment of chronic periodontitis in a Brazilian population II--microbiological results. J Clin Periodontol. 2005 Apr;32(4):406-11. doi: 10.1111/j.1600-051X.2005.00720.x.

Results Reference

background

PubMed Identifier

17618330

Citation

Moeintaghavi A, Talebi-ardakani MR, Haerian-ardakani A, Zandi H, Taghipour S, Fallahzadeh H, Pakzad A, Fahami N. Adjunctive effects of systemic amoxicillin and metronidazole with scaling and root planing: a randomized, placebo controlled clinical trial. J Contemp Dent Pract. 2007 Jul 1;8(5):51-9.

Results Reference

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Full-mouth Periodontal Debridement and Metronidazole Gel in Patients With Chronic Periodontitis

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