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

Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880448
• Other study ID #: 12/207
• Status: Completed
• Phase: N/A
• Start date: September 19, 2012
• Est. completion date: January 15, 2018

Study information

• Verified date: March 2019
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis
• Surgery

Intervention

Drug:
• Metronidazole
Metronidazole 500mg/8h/7days
• Placebo
Cornstarch 500mg/8h/7days

Procedure:
• periodontal surgery
periodontal surgery

Locations

Country	Name	City	State
Spain	Faculty of Dentistry, University Complutense	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Probing Pocket Depth (PPD)	Full mouth measurement of the distance in mm from the gingival margin to the bottom of the periodontal pocket at 6 sites per tooth with a manual periodontal probe University North Carolina 15 (UNC-15mm)	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)
Secondary	Gingival Recession (REC)	Full mouth measurement of the distance in mm from the cemento-enamel junction to the gingival margin at 6 sites per tooth with a manual periodontal probe University North Carolina 15 (UNC-15mm)	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)
Secondary	Full mouth plaque score (FMPS)	Full mouth measurement at 6 sites per tooth of the presence/abscence of dental biofilm (plaque) with a manual periodontal probe University North Carolina 15 (UNC-15mm). Dichotomous evaluation: 0: absence of plaque; 1: presence of plaque)	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)
Secondary	Full mouth bleeding score (FMBS)	Full mouth measurement of the bleeding on probing at 6 sites per tooth with a manual periodontal probe University North Carolina 15 (UNC-15mm). Dichotomous evaluation: 0: absence of bleeding on probing; 1: presence of bleeding on probing)	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)
Secondary	Furcation lesions	Measurement of the degree of furcation lesions (0,I,II,III) with a Nabers periodontal probe	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)
Secondary	Clinical attachment level (CAL)	Full mouth measurement of the distance in mm from cemento-enamel junction to the bottom of the periodontal pocket (REC+PPD) at 6 sites per tooth with a manual periodontal probe University North Carolina 15 (UNC-15mm)	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)
Secondary	Total Bacterial Counts	A microbiological sample is taken with sterilized paper points from the gingival crevicular fluid and the total bacterial counts (expressed in colony forming units/ml) are analyzed by culture.	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)
Secondary	Percentage of periodontal pathogens	Determination of the percentage of the following periodontal pathogens: Porphyromonas gingivalis; Tannerella forsythia; Aggregatibacter actinomycetemcomitans; Prevotella intermedia/nigrescens; Parvimonas micra; Fusobacterium nucleatum; Eikenella corrodens; Campylobacter rectus; Capnocytophaga sp.; Eubacterium sp.	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)
Secondary	Counts of periodontal pathogens	Determination of the percentage of the following periodontal pathogens: Porphyromonas gingivalis; Tannerella forsythia; Aggregatibacter actinomycetemcomitans; Prevotella intermedia/nigrescens; Parvimonas micra; Fusobacterium nucleatum; Eikenella corrodens; Campylobacter rectus; Capnocytophaga sp.; Eubacterium sp.	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)
Secondary	Ocurrence of side effects	The patient was asked if the had experience any adverse effect and a questionnaire was filled in. (Yes/No)	1 week after the last surgery + pills intake (placebo or metronidazole)
Secondary	Adverse Effect Description	The patient was asked to freely describe the adverse effect he had experienced in the case he had.	1 week after the last surgery + pills intake (placebo or metronidazole)
Secondary	Degree of affectation of an adverse effect	The patient was asked to categorize the degree of affectation of the adverse effect (mild, moderate or severe) in case he had experience any.	1 week after the last surgery + pills intake (placebo or metronidazole)
Secondary	Patient Compliance	The patient was asked to bring the recipient with the pills 1 week after the last surgery in order to evaluate how many of them were left and so evaluate their compliance to the prescription dosage. We calculate the percentage of pills the patient takes according to the prescription (1 pill every 8 hours for 7 days - Total of 21 pills)	1 week after the last surgery + pills intake (placebo or metronidazole)