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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880448
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Elena Figuero, Universidad Complutense de Madrid

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.

Condition or disease Intervention/treatment Phase
Periodontitis Surgery Drug: Metronidazole Drug: Placebo Procedure: periodontal surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
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
Actual Study Start Date : September 19, 2012
Actual Primary Completion Date : January 15, 2018
Actual Study Completion Date : January 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metronidazole + periodontal surgery
Periodontal surgery + Metronidazole (metronidazole 500mg/8h/7days)
Drug: Metronidazole
Metronidazole 500mg/8h/7days

Procedure: periodontal surgery
periodontal surgery

Placebo Comparator: Placebo + periodontal surgery
Periodontal surgery + Placebo (cornstarch 500mg/8h/7days)
Drug: Placebo
Cornstarch 500mg/8h/7days

Procedure: periodontal surgery
periodontal surgery




Primary Outcome Measures :
  1. Probing Pocket Depth (PPD) [ Time Frame: 6 weeks after scaling and root planing compared to 12 months after the surgery ]
    Full mouth measurement at 6 sites per tooth with a manual periodontal probe University North Carolina 15 (UNC-15mm)


Secondary Outcome Measures :
  1. Probing Pocket Depth (PPD) [ Time Frame: 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 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)

  2. Gingival Recession (REC) [ Time Frame: 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 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)

  3. Full mouth plaque score (FMPS) [ Time Frame: 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 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)

  4. Full mouth bleeding score (FMBS) [ Time Frame: 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 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)

  5. Furcation lesions [ Time Frame: 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) ]
    Measurement of the degree of furcation lesions (0,I,II,III) with a Nabers periodontal probe

  6. Clinical attachment level (CAL) [ Time Frame: 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 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)

  7. Total Bacterial Counts [ Time Frame: 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) ]
    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.

  8. Percentage of periodontal pathogens [ Time Frame: 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) ]

    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.

  9. Counts of periodontal pathogens [ Time Frame: 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) ]

    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.

  10. Ocurrence of side effects [ Time Frame: 1 week after the last surgery + pills intake (placebo or metronidazole) ]
    The patient was asked if the had experience any adverse effect and a questionnaire was filled in. (Yes/No)

  11. Adverse Effect Description [ Time Frame: 1 week after the last surgery + pills intake (placebo or metronidazole) ]
    The patient was asked to freely describe the adverse effect he had experienced in the case he had.

  12. Degree of affectation of an adverse effect [ Time Frame: 1 week after the last surgery + pills intake (placebo or metronidazole) ]
    The patient was asked to categorize the degree of affectation of the adverse effect (mild, moderate or severe) in case he had experience any.

  13. Patient Compliance [ Time Frame: 1 week after the last surgery + pills intake (placebo or metronidazole) ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880448


Locations
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Spain
Faculty of Dentistry, University Complutense
Madrid, Spain, 28040
Sponsors and Collaborators
Universidad Complutense de Madrid
Investigators
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Study Director: Mariano Sanz Alonso University Complutense Madrid (UCM)
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Responsible Party: Prof. Elena Figuero, Principal Investigator, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT03880448    
Other Study ID Numbers: 12/207
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Elena Figuero, Universidad Complutense de Madrid:
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
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents