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Clarithromycin as Adjuvant to Periodontal Debridement

NCT ID: NCT02829983

Last Updated: 2017-11-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-11-30

Brief Summary

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To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.

Detailed Description

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To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.Forty patients were select and randomly assigned into two groups: Group clarithromycin with 20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days; group placebo with 20 subjects that received FMUD associated with placebo. Probing depth (PD), gain in clinical attachment level (CAL) and bleeding on probing (BOP) were evaluated at baseline, 3 and 6 months post- operatively.

Conditions

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Aggressive Periodontitis

Keywords

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clarithromycin periodontal debridement aggressive periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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clarithromycin group

20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.

Group Type ACTIVE_COMPARATOR

Clarithromycin

Intervention Type DRUG

Use of 500mg of Clarithromycin twice a day for 3 days

One-stage full-mouth ultrasonic debridement (FMUD)

Intervention Type OTHER

One session of Periodontal debridement using ultrasonic device.

placebo group

20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Use of placebo tablets twice a day for 3 days.

One-stage full-mouth ultrasonic debridement (FMUD)

Intervention Type OTHER

One session of Periodontal debridement using ultrasonic device.

Interventions

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Clarithromycin

Use of 500mg of Clarithromycin twice a day for 3 days

Intervention Type DRUG

Placebo

Use of placebo tablets twice a day for 3 days.

Intervention Type DRUG

One-stage full-mouth ultrasonic debridement (FMUD)

One session of Periodontal debridement using ultrasonic device.

Intervention Type OTHER

Other Intervention Names

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macrolide

Eligibility Criteria

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Inclusion Criteria

* diagnosis of Generalized Aggressive Periodontitis
* presence of ≥20 teeth
* presence of ≥ 6 sites presenting probing depth (PD) ≥5mm with bleeding on probing (BOP) and ≥2 sites with PD ≥7mm (including incisors and first molars, in addition to two other non-contiguous teeth between them)
* good general health
* \<35 years of age
* agree to participate in the study and sign a written consent

Exclusion Criteria

* pregnant or lactating
* suffering from any other systemic disease (e.g. cardiovascular, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease
* received antimicrobials in the previous 6 months
* taking long-term anti-inflammatory drugs
* received a course of periodontal treatment within the last 12 months
* smoked
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role lead

Responsible Party

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Mauro Pedrine Santamaria

DDS,MS,PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mauro P Santamaria, DDS, PhD

Role: STUDY_DIRECTOR

UPECLIN HC FM Botucatu Unesp

References

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Casarin RC, Peloso Ribeiro ED, Sallum EA, Nociti FH Jr, Goncalves RB, Casati MZ. The combination of amoxicillin and metronidazole improves clinical and microbiologic results of one-stage, full-mouth, ultrasonic debridement in aggressive periodontitis treatment. J Periodontol. 2012 Aug;83(8):988-98. doi: 10.1902/jop.2012.110513. Epub 2012 Jan 30.

Reference Type RESULT
PMID: 22288485 (View on PubMed)

Hammami C, Nasri W. Antibiotics in the Treatment of Periodontitis: A Systematic Review of the Literature. Int J Dent. 2021 Nov 8;2021:6846074. doi: 10.1155/2021/6846074. eCollection 2021.

Reference Type DERIVED
PMID: 34790237 (View on PubMed)

Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2.

Reference Type DERIVED
PMID: 33197289 (View on PubMed)

Andere NMRB, Castro Dos Santos NC, Araujo CF, Mathias IF, Taiete T, Casarin RCV, Jardini MAN, Shaddox LM, Santamaria MP. Clarithromycin as an Adjunct to One-Stage Full-Mouth Ultrasonic Periodontal Debridement in Generalized Aggressive Periodontitis: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Dec;88(12):1244-1252. doi: 10.1902/jop.2017.170165. Epub 2017 Jul 3.

Reference Type DERIVED
PMID: 28671507 (View on PubMed)

Other Identifiers

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NMRBA

Identifier Type: -

Identifier Source: org_study_id