Metronidazole vs Azithromycin in Periodontal Surgery for Patients Positive to Porphyromonas Gingivalis

NCT03862456 | Unknown

• 1 other identifier: ATB1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine whether, in patients with non treated periodontitis (stage III and IV) positive to Porphyromonas gingivalis, the use of systemic antimicrobials (metronidazole versus azithromycin) as an adjunctive treatment to periodontal surgery provides clinical and microbiological benefits.

Conditions

Periodontitis; Surgery

Keywords

Disease Progression; Microbiota; Periodontitis/surgery; Periodontitis/therapy; Periodontitis/drug effect; Periodontitis/drug therapy; Periodontal diseases/surgery; Periodontal diseases/therapy; Periodontal pocket/surgery; Periodontal pocket/therapy; Periodontal pocket/drug therapy; Azithromycin/therapeutic use; Metronidazole/therapeutic use; Azithromycin; Metronidazole; Porphyromonas gingivalis

Outcome Measures

Primary Outcomes (1)

• Probing pocket depth (PPD)

  Full mouth measurement at 6 sites per tooth, with a manual periodontal probe University North Carolina 15 (UNC-15 mm)

  At 6 weeks after periodontal surgery

Secondary Outcomes (12)

• Probing pocket depth (PPD)

  At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery)

• Gingival Recession (REC)

  At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery)

• Plaque index (PlI)

  At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery)

• Gingival index (GI)

  At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery)

• Furcations

  At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery)

Study Arms (2)

azythromycin + periodontal surgery.

EXPERIMENTAL

Periodontal surgery + Azithromycin (500 mg every 24 h for 3 days).

Other: Azithromycin

metronidazole + periodontal surgery

ACTIVE COMPARATOR

Periodontal surgery + Metronidazole (500 mg every 8 h for 7 days).

Other: Metronidazole

Interventions

Azithromycin OTHER

azithromycin (500 mg/24h/3 days)

azythromycin + periodontal surgery.

Metronidazole OTHER

metronidazole (500 mg/8h/7 days)

metronidazole + periodontal surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of periodontitis (stages III or IV) that may require periodontal surgery
• Have at least 10 teeth in function, excluding third molars.
• Present locations with probing depth (PS)\> 6 mm in at least 30% of the teeth.
• Present radiographic evidence of moderate-severe bone loss in at least 30% of the dentition.
• Detection of P. gingivalis in subgingival samples taken at the screening visit as well as in the post-scaling and root planning visit and processed by culture.
• Systemically healthy patients.

You may not qualify if:

• Pregnant or lactating women.
• Presenting systemic pathology and / or taking medication that may affect the periodontal situation and / or patients requiring antibiotic prophylaxis.
• Have received systemic antimicrobial treatment in the previous 6 months.
• Have received periodontal treatment in the 6 months prior to the beginning of the study.
• Patients allergic to metronidazole, or to any of the components of commercial formulations thereof (Flagyl®).
• Patients allergic to azithromycin, or to any of the components of commercial formulations thereof (Zithromax®).
• Patients who refuse to sign the informed consent.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Faculty of Dentistry, Univesity Complutense, Madrid

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Periodontitis; Disease Progression; Periodontal Diseases; Periodontal Pocket

Interventions

Azithromycin; Metronidazole

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mariano Sanz

  University Complutense Madrid (UCM)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subjects were randomly assigned to the treatment groups in ascending order according to a balanced distribution system through a computer generated random number design table (random block design). Randomization was balanced according to the smoking habit at the initial visit to ensure homogeneity in the treatment groups. The method of allocation concealment selected were opaque envelopes. The research coordinator was responsible for the randomization and allocation of patients. The 50 opaque envelopes (25 / group) were prepared.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: March 5, 2019
• Study Start: January 1, 2013
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: March 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)