Metronidazole vs Placebo as Adjuncts to Periodontal Surgery for Patients Positive to Porphyromonas Gingivalis

• Status: Completed
• Trial end date: 2018-01-15
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to determine whether the use of a systemic antimicrobial (metronidazole) as an adjunct to periodontal surgery provides additional clinical and microbiological beneficial effects compared to periodontal surgery alone plus a placebo, in patients with non treated periodontitis (stage III and IV) positive to Porphyromonas gingivalis.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidad Complutense de Madrid
• Treatments: Metronidazole

Criteria

Inclusion Criteria:

• Diagnosis of generalized severe chronic periodontitis (Armitage 1999) or periodontitis stages III or IV (Papapanou et al., 2018) that may require periodontal surgery.

• Have at least 10 teeth in function, excluding third molars.

• Present sites with pocket probing depth (PPD) ≥ 6mm in ≥ 2 teeth in ≥ one quadrant

• Present radiographic evidence of ≥ 30 % bone loss in ≥ 30% of the dentition

• Detection of Porphyromonas gingivalis in subgingival samples taken at the screening visit as well as in the post-scaling and root planing visit and processed by culture.

• Systemically healthy patients.

Exclusion Criteria:

• Pregnant or lactating women.

• Systemic pathology and/or taking medication that may affect the periodontal situation and/or patients requiring antibiotic prophylaxis.

• Have received systemic antimicrobial treatment 6 months prior to the beginning of the study.

• Have received periodontal treatment 6 months prior to the beginning of the study.

• Patients allergic to metronidazole.

• Patients allergic to cornstarch.

• Patients who refuse to sign the informed consent.