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

NCT03880448 | Completed

• 1 other identifier: 12/207
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

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/drug therapy; Metronidazole/therapeutic use; Metronidazole; Porphyromonas gingivalis; Systemic antimicrobial/periodontal surgery

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-15mm)

  6 weeks after scaling and root planing compared to 12 months after the surgery

Secondary Outcomes (13)

• Probing Pocket Depth (PPD)

  At baseline (before scaling and root planing), 6 weeks after scaling and root planing (Reevaluation Phase I) and during the maintenance Phase III (3, 6 and 12 months after periodontal surgery)

• Gingival Recession (REC)

  At baseline (before scaling and root planing), 6 weeks after scaling and root planing (Reevaluation Phase I) and during the maintenance Phase III (3, 6 and 12 months after periodontal surgery)

• Full mouth plaque score (FMPS)

  At baseline (before scaling and root planing), 6 weeks after scaling and root planing (Reevaluation Phase I) and during the maintenance Phase III (3, 6 and 12 months after periodontal surgery)

• Full mouth bleeding score (FMBS)

  At baseline (before scaling and root planing), 6 weeks after scaling and root planing (Reevaluation Phase I) and during the maintenance Phase III (3, 6 and 12 months after periodontal surgery)

• Furcation lesions

  At baseline (before scaling and root planing), 6 weeks after scaling and root planing (Reevaluation Phase I) and during the maintenance Phase III (3, 6 and 12 months after periodontal surgery)

Study Arms (2)

Metronidazole + periodontal surgery

EXPERIMENTAL

Periodontal surgery + Metronidazole (metronidazole 500mg/8h/7days)

Drug: Metronidazole; Procedure: periodontal surgery

Placebo + periodontal surgery

PLACEBO COMPARATOR

Periodontal surgery + Placebo (cornstarch 500mg/8h/7days)

Drug: Placebo; Procedure: periodontal surgery

Interventions

Metronidazole DRUG

Metronidazole 500mg/8h/7days

Metronidazole + periodontal surgery

Placebo DRUG

Cornstarch 500mg/8h/7days

Placebo + periodontal surgery

periodontal surgery PROCEDURE

periodontal surgery

Metronidazole + periodontal surgery; Placebo + 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Faculty of Dentistry, University Complutense

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Periodontitis; Disease Progression; Periodontal Diseases

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mariano Sanz Alonso

  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 patient allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 19, 2019
• Study Start: September 19, 2012
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)