Clinical trial NCT03880448: Metronidazole vs Placebo as Adjuncts to Periodontal Surgery for Patients Positive to Porphyromonas Gingivalis
Official title: Clinical and Microbiological Evaluation of Metronidazole as a Systemic Antimicrobial Adjunct to Periodontal Surgery in the Treatment of Patients With Periodontitis Positive to Porphyromonas Gingivalis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Design: pilot, randomized, parallel, placebo controlled and triple blind clinical trial.

Sample: Patients with generalized severe chronic periodontitis (stages III and IV) and positive to Porphyromonas gingivalis who potentially need periodontal surgery were recruited from those who attended the postgraduate program in periodontics at the Complutense University in Madrid.

Patients were randomly assigned to the test group (periodontal surgery + metronidazole) or control group (periodontal surgery + placebo).

Study visits:

* Examiner calibration
* Recruitment of patients. Screening. Data collection (clinical and microbiological variables)
* Phase I

  * Non surgical periodontal therapy (2 visits) performed by second year students.
  * Reevaluation at 6 weeks. Data collection (clinical and microbiological variables).

Identification of study participants (patients with probing pocket depth \> 5mm in ≥ 2 teeth per sextant or those presenting multiple sites with probing pocket depth ≥ 5mm and bleeding on probing in ≥ one mouth quadrant and positive to Porphyromonas gingivalis.

The need of the surgical procedure was supervised in every case by more than one experienced periodontist (clinical teachers). Finally patients were randomly assigned to their study groups.

* Phase II. Surgical Periodontal Therapy

  * Periodontal surgery sessions performed by second year students. In the last surgery the patient received a recipient containing the pills (metronidazole or placebo according to randomization) and the instructions for use.
  * Suture removal 1 week after the surgery. Data collection 1 week after antibiotic consumption after the last surgery (patient-centered variables on the side effects of antibiotics). Pills recipients were collected in order to evaluate patient compliance. An individual not involved in the study protocol was in charge of doing the data and recipient collection.
* Phase III. Periodontal Maintenance.

  * Maintenance 1(3 months postsurgery). Data collection (clinical and microbiological variables)
  * Maintenance 2 (6 months postsurgery). Data collection (clinical and microbiological variables)
  * Maintenance 3 (9 months postsurgery).
  * Maintenance 4 (12 months postsurgery). Data collection (clinical and microbiological variables)

Security protocol:

Any patient exhibiting worsening in periodontal clinical parameters during the maintenance phase were excluded from the study and inestable sites were re-treated. Inestable sites were considered those exhibiting clinical attachment loss \> 2mm between two consecutive visits (Haffajee et al. 1983) after the treatment.

Eligibility 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.

Primary outcomes:
measure: Probing Pocket Depth (PPD)
timeFrame: 6 weeks after scaling and root planing compared to 12 months after the surgery
Secondary outcomes:
measure: Probing Pocket Depth (PPD)
timeFrame: 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)
measure: Gingival Recession (REC)
timeFrame: 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)
measure: Full mouth plaque score (FMPS)
timeFrame: 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)
measure: Full mouth bleeding score (FMBS)
timeFrame: 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)
measure: Furcation lesions
timeFrame: 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)
measure: Clinical attachment level (CAL)
timeFrame: 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)
measure: Total Bacterial Counts
timeFrame: 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)
measure: Percentage of periodontal pathogens
timeFrame: 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)
measure: Counts of periodontal pathogens
timeFrame: 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)
measure: Ocurrence of side effects
timeFrame: 1 week after the last surgery + pills intake (placebo or metronidazole)
measure: Adverse Effect Description
timeFrame: 1 week after the last surgery + pills intake (placebo or metronidazole)
measure: Degree of affectation of an adverse effect
timeFrame: 1 week after the last surgery + pills intake (placebo or metronidazole)
measure: Patient Compliance
timeFrame: 1 week after the last surgery + pills intake (placebo or metronidazole)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Faculty of Dentistry, University Complutense
Study officials:
affiliation: University Complutense Madrid (UCM)
name: Mariano Sanz Alonso
role: STUDY_DIRECTOR
References: