PeriodontitisNCT03880448
Metronidazole vs Placebo as Adjuncts to Periodontal Surgery for Patients Positive to Porphyromonas Gingivalis
A study testing Metronidazole and periodontal surgery in people with Periodontitis and Surgery, run by Universidad Complutense de Madrid at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Surgery
- What is being tested?
- Metronidazole and periodontal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteSpain
- Study dates
- 19 Sep 2012to 15 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Periodontitis, Surgery
- Being tested
- Metronidazole, Placebo, periodontal 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
- Medical subject headings
- Periodontitis, Disease Progression, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Metronidazole 500mg/8h/7days
PlaceboDrug
Cornstarch 500mg/8h/7days
periodontal surgeryProcedure or surgery
periodontal surgery
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole + periodontal surgery | Experimental | Periodontal surgery + Metronidazole (metronidazole 500mg/8h/7days) Receives: Drug: Metronidazole; Procedure: periodontal surgery |
| Placebo + periodontal surgery | Placebo comparator | Periodontal surgery + Placebo (cornstarch 500mg/8h/7days) Receives: Drug: Placebo; Procedure: periodontal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pocket Depth (PPD)
Full mouth measurement at 6 sites per tooth with a manual periodontal probe University North Carolina 15 (UNC-15mm)
Measured: 6 weeks after scaling and root planing compared to 12 months after the surgery
Secondary outcomes (13)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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
Measurement of the degree of furcation lesions (0,I,II,III) with a Nabers periodontal probe
Measured: 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)
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)
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Ocurrence of side effects
The patient was asked if the had experience any adverse effect and a questionnaire was filled in. (Yes/No)
Measured: 1 week after the last surgery + pills intake (placebo or metronidazole)
Adverse Effect Description
The patient was asked to freely describe the adverse effect he had experienced in the case he had.
Measured: 1 week after the last surgery + pills intake (placebo or metronidazole)
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.
Measured: 1 week after the last surgery + pills intake (placebo or metronidazole)
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)
Measured: 1 week after the last surgery + pills intake (placebo or metronidazole)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start19 Sep 2012
- Primary completion15 Jan 2018
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Elena Figuero, Universidad Complutense de Madrid
- Investigators
- Mariano Sanz Alonso, Study director, University Complutense Madrid (UCM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880448
- Sponsor's protocol ID
- 12/207
- Status last verified
- Mar 2019
- First submitted
- 15 Mar 2019
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03880448
- Acronym / sponsor ID
- 12/207
- Conditions
- Periodontitis, Surgery
- Keywords
- Disease Progression, Microbiota, Periodontitis/surgery, Periodontitis/therapy, Periodontitis/drug effect, Periodontitis/drug therapy, Periodontal diseases/surgery, Periodontal diseases/therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 19 Sep 2012 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronidazole + periodontal surgery | Experimental | Drug: Metronidazole, Procedure: periodontal surgeryPeriodontal surgery + Metronidazole (metronidazole 500mg/8h/7days) |
| Placebo + periodontal surgery | Placebo comparator | Drug: Placebo, Procedure: periodontal surgeryPeriodontal surgery + Placebo (cornstarch 500mg/8h/7days) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetronidazoleMetronidazole 500mg/8h/7days | Drug | Metronidazole + periodontal surgery |
| PlaceboCornstarch 500mg/8h/7days | Drug | Placebo + periodontal surgery |
| periodontal surgeryperiodontal surgery | Procedure or surgery | Metronidazole + periodontal surgery, Placebo + periodontal surgery |
Primary outcome
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)
13 secondary outcomes
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)
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 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 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)
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)
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)
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)
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)
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)
Ocurrence of side effects
Time frame: 1 week after the last surgery + pills intake (placebo or metronidazole)
Adverse Effect Description
Time frame: 1 week after the last surgery + pills intake (placebo or metronidazole)
Degree of affectation of an adverse effect
Time frame: 1 week after the last surgery + pills intake (placebo or metronidazole)
Patient Compliance
Time frame: 1 week after the last surgery + pills intake (placebo or metronidazole)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariano Sanz Alonso study director
University Complutense Madrid (UCM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metronidazole and periodontal surgery in people with Periodontitis and Surgery, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Pocket Depth (PPD) (time frame: 6 weeks after scaling and root planing compared to 12 months after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.