Condition category
Oral Health
Date applied
22/11/2020
Date assigned
04/12/2020
Last edited
03/12/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Periodontitis, also called gum disease, is a serious gum infection that damages the soft tissue and, without treatment, can destroy the bone that supports your teeth. Periodontitis can cause teeth to loosen or lead to tooth loss.
Some studies have shown that the use of antibiotics can provide some benefits. However, there are no studies that have evaluated how well metronidazole works as an antibiotic in surgical periodontal therapy. Therefore, the objective of our study was to determine whether the use of an antibiotic (metronidazole), as an added treatment to periodontal surgery, provides additional clinical and microbiological benefits, in patients with generalized severe periodontitis.

Who can participate?
Systemically healthy patients of both genders, aged 18 years or older, diagnosed with generalized severe periodontitis.

What does the study involve?
Participants are randomly allocated to receive adjunctive metronidazole or placebo. Clinical variables were recorded at baseline, 6 weeks after subgingival instrumentation, and after 3, 6 and 12 months. Microbiological samples were taken at the initial and final visits and analyzed by multiplex quantitative polymerase chain reaction (qPCR).

What are the possible benefits and risks of participating?
In this study, patients will benefit from non-surgical and surgical periodontal treatment of periodotitis. The treatment is expected to obtain improvements in periodontal clinical parameters such as a decrease in probing depth, gain in the level of clinical attachment, and resolution of inflammation. A greater decrease in bacterias would also be expected in the test group receiving the antibiotics. Although the adverse and unwanted effects associated with the use of systemic antibiotics must be taken into consideration.

Where is the study run from?
Pontificia Universidad Católica Madre y Maestra (Dominican Republic)

When is the study starting and how long is it expected to run for?
April 2014 to May 2019

Who is funding the study?
Pontificia Universidad Católica Madre y Maestra (Dominican Republic)

Who is the main contact?
Dr James R. Collins
jamescollins@pucmm.edu.do

Trial website

Contact information

Type

Scientific

Primary contact

Prof James Collins

ORCID ID

Contact details

Av Abraham Lincoln esq. Simón Bolivar
Santo Domingo
1101
Dominican Republic
+1 (0)8094810572
jamescollins@pucmm.edu.do

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Adjunctive efficacy of systemic metronidazole in the surgical treatment of periodontitis: a randomized placebo-controlled clinical trial

Acronym

Study hypothesis

To determine whether the use of a systemic antimicrobial (metronidazole), as an adjunctive treatment to periodontal surgery (step 3), provides additional clinical and microbiological benefits, in patients with severe generalised chronic periodontitis (generalised stages III-IV, grades B-C periodontitis).

Ethics approval

Approved 12/03/2015, Ethical Committee of the Faculty of Health (COBE) of the Pontificia Universidad Católica Madre y Maestra (PUCMM) (Autopista Duarte Km 1 1/2, Santiago, República Dominicana; +1 (809) 580-1962, ext. 4416; brodriguez@pucmm.edu.do), ref: COBE-FACS-EXT-003-1-2014-2015

Study design

Randomized parallel placebo-controlled double-blinded clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Severe generalised chronic periodontitis (generalised stages III-IV, grades B-C periodontitis)

Intervention

Participants are randomly assigned to treatment groups in ascending order, at the time of surgery, according to a balanced distribution system (random block design, block size = 6).
1. Test group: blisters consisted of 500 mg metronidazole, to be taken three times per day for 7 days after the last surgery
2. Placebo group

In the initial evaluation, a clinical examination is carried out to establish the periodontal diagnosis. Clinical measurements include: PD and gingival recession/overgrowth (REC), measured to the nearest millimeter; CAL, calculated as the sum⁄rest of PD and REC; bleeding on probing (BOP), assessed dichotomously. Plaque index (PlI) is also assessed. In each quadrant, the most accessible location with the deepest PD and BOP is selected. Subgingival plaque samples are obtained at the same sites throughout the study at the deepest site of each quadrant. All participants receive motivational sessions on oral hygiene instructions and scaling and root planning. Six weeks after the last session of SRP, the re-evaluation is performed and a new full periodontal examination is performed. Those presenting multiple locations with PD ≥5 mm with BOP in ≥1 quadrant received periodontal surgery through open flap debridment. After the last surgical procedure is performed, the medication is provided to the participants, with the instructions to start with the drug regime, three times a day for 7 days. Clinical parameters are recorded 3 months after the last surgery session, and then after 6 and 12 months. Following the active treatment, at 3, 6, 9 and 12 months all patients receive a full mouth professional mechanical plaque removal (PMPR), including SRP as needed and polishing of all dental surfaces present, in both groups.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Probing Depth (PD), measured using a UNC-15 mm periodontal probe (Hu-Friedy, Leinmen, Germany) at baseline and 12-month visit

Secondary outcome measures

At baseline, 3 months after the last surgery session, and then after 6 and 12 months:
1. Probing Depth distribution [⁄overgrowth (measured to the nearest millimeter), Clinical Attachment Loss (calculated as the sum⁄rest of PD and REC) and open pockets measured using a UNC-15 mm periodontal probe (Hu-Friedy, Leinmen, Germany)
2. Plaque Index recorded using the O'Leary Index
3. Bleeding on Probing measured using a dichotomous analysis (presence or absence)

4. Microbiological variables (frequency of detection and counts of each targeted bacteria) samples analysed by multiplex quantitative polymerase chain reaction (qPCR), at baseline and after 12 months following surgical therapy

Overall trial start date

29/04/2014

Overall trial end date

15/05/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Severe generalized chronic periodontitis (Armitage, 1999), corresponding to generalized stage III-IV periodontitis, with grades B-C (Caton et al., 2018; Papapanou et al., 2018; Tonetti, Greenwell, & Kornman, 2018)
2. A least 10 teeth in function, excluding third molars
3. Sites with PD> 5 mm, in ≥2 teeth in ≥1 quadrant
4. Radiographic evidence of bone loss ≥30% in, at least, 30% of the dentition
5. Older than 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Two groups with 25 patients each

Total final enrolment

40

Participant exclusion criteria

1. Pregnant or breastfeeding women
2. Systemic diseases and/or chronic medications that may affect the periodontal status and /or requiring antibiotic prophylaxis
3. Having received systemic antimicrobial treatment in the previous 3 months
4. Have received periodontal treatment in the 6 months prior to the start of the study
5. Allergic to metronidazole, or to any of the components of their commercial formulations (Metrex 500 mg®, Laboratorio Union SRL, Santo Domingo, República Dominicana)
6. Refuse to sign the informed consent
7. Smokers ≥10 cigarettes/day

Recruitment start date

10/02/2015

Recruitment end date

15/02/2018

Locations

Countries of recruitment

Dominican Republic

Trial participating centre

Pontificia Universidad Católica Madre y Maestra (PUCMM-CSD)
Av Abraham Lincoln esq. Simón Bolivar
Santo Domingo
10109
Dominican Republic

Sponsor information

Organisation

Pontificia Universidad Católica Madre y Maestra

Sponsor details

Av Abraham Lincoln esq. Simón Bolivar
Santo Domingo
10109
Dominican Republic
+1 (0)8095350111 Ext. 2094
jeanmybautista@pucmm.edu.do

Sponsor type

University/education

Website

https://www.pucmm.edu.do/

Funders

Funder type

University/education

Funder name

Pontificia Universidad Católica Madre y Maestra

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Study protocol can be available on request. Planned publication in a high-impact peer-reviewed journal.

Intention to publish date

10/03/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/12/2020: Trial’s existence confirmed by Ethical Committee of the Faculty of Health (COBE) of the Pontificia Universidad Católica Madre y Maestra.