Phase 3
N=46
Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis
Aggressive Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT02969928 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Change in Clinical Attachment Level (CAL) — 3.69; 3.62; 2.4; 3 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Full-mouth ultrasonic debridement (Procedure); Clarithromycin (Drug); Amoxicillin (Drug); Metronidazole (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinical Attachment Level (CAL) |
3.69; 3.62; 2.4; 3; 3; 3 | — |
| SECONDARY Change in Probing Depth (PB) |
3.44; 3.41; 2.5; 2.7; 2.6; 2.7 | — |
| SECONDARY Change in Bleeding on Probe (BoP) |
53.4; 43.7; 30.2; 24.8; 27.3; 23.3 | — |
Summary
The aim of this study is to assess the clinical outcomes of full-mouth ultrasonic debridement combined with clarithromycin or amoxicillin + metronidazole association for the treatment of generalized aggressive periodontitis (GAgP).
Eligibility Criteria
Inclusion Criteria
- diagnosis of GAgP (AAP, 1999);
- presence of ≥20 teeth;
- presence of ≥ 6 sites presenting PD ≥ 5mm with bleeding on probing (BOP) and ≥2 sites with PD ≥7mm (including incisors and first molars, in addition to other two non-contiguous teeth);
- good general health;
- ≤ 35 years old; and
- agree to participate in the study and sign a written informed consent. All subjects will be individually informed about the objectives, probable risks and benefits of the protocol treatment (according to Resolution nº196 of October 1996 and to the Professional Code of Dental Ethics - 179/93).
Exclusion Criteria
- pregnancy or lactating;
- suffer from any systemic disease (e.g. cardiovascular disorders, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease;
- took antimicrobials in the previous 6 months;
- taking long-term anti-inflammatory drugs;
- previous periodontal treatment within the last 12 months;
- smokers.
Data sourced from ClinicalTrials.gov (NCT02969928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.