NCT07592416

Brief Summary

Although robust evidence supports the benefits of antibiotics in periodontal treatment, the potential adverse effects of this therapy cannot be overlooked. These include concerns regarding the emergence of antimicrobial resistance and the non-ecological impact of antimicrobials on the gut microbiome, which may be closely linked to the etiopathogenesis of periodontitis and to the maintenance of long-term periodontal treatment outcomes. In this context, probiotics may represent a promising alternative strategy to reduce the need for antibiotics, particularly in severe cases of periodontitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Aug 2023

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

2.4 years

First QC Date

April 28, 2026

Last Update Submit

May 13, 2026

Conditions

Healthy Adult ParticipantsPeriodontal Disease

Keywords

periodontitisperiodontal diseaseprobioticsantibiotics

Outcome Measures

Primary Outcomes (6)

  • Periodontal Probing Depth (PD)

    A full-mouth periodontal examination will be performed using a North Carolina periodontal probe (Hu-Friedy, Chicago, IL, USA). Probing depth (PD) will be measured in millimeters at six sites per tooth.

    every 3 months, up to 1 year

  • Clinical Attachment Level (CAL)

    Clinical attachment level (CAL) will be measured in millimeters at six sites per tooth using a North Carolina periodontal probe.

    Every 3 months, up to 1 year

  • Bleeding on Probing (BOP)

    Bleeding on probing will be assessed dichotomously (presence/absence) at six sites per tooth during full-mouth periodontal examination

    Every 3 months, up to 1 year

  • Visible Supragingival Biofilm

    Presence or absence of visible supragingival biofilm will be assessed on four tooth surfaces during full-mouth periodontal examination.

    Every 3 months, up to 1 year

  • Distance from Cementoenamel Junction to Gingival Margin

    The distance from the cementoenamel junction to the gingival margin will be measured in millimeters at six sites per tooth.

    Every 3 months, up to 1 year

  • Suppuration

    Suppuration will be assessed dichotomously (presence/absence) at six sites per tooth during periodontal examination.

    Every 3 months, up to 1 year

Study Arms (3)

Placebo

NO INTERVENTION

Probiotic

EXPERIMENTAL

To compare the effects of probiotic as an adjuvant therapy

Other: Probiotic Therapy

Antibiotic

EXPERIMENTAL

To compare the effects as an adjuvant therapy

Drug: Amoxicilin and Metronidazole

Interventions

Amoxicilin and MetronidazoleDRUG

The antibiotic group will receive amoxicilin and metronidazole, the probiotic group will receive probiotics

Also known as: Amoxicilin, Metronidazole, Antibiotics
Antibiotic
Probiotic TherapyOTHER

Patients will receive probiotic lozenges as an adjuvant therapy to periodontal treatment.

Probiotic

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults with a diagnosis of generalized periodontitis, defined as involvement of ≥30% of teeth, classified as: Stage III or Stage IV, and Grade B or Grade C, according to the 2018 classification.
  • Presence of at least one tooth with ≥1 interproximal site exhibiting: Probing depth (PD) ≥6 mm, and Clinical attachment loss (CAL) ≥5 mm.
  • Presence of at least 15 teeth, excluding third molars and teeth indicated for extraction.
  • Presence of at least 6 non contiguous teeth, each with ≥1 interproximal site presenting PD and CAL ≥5 mm.

You may not qualify if:

  • Current smokers or former smokers who quit less than 5 years prior to enrollment.
  • Pregnant or breastfeeding women.
  • History of periodontal treatment within the previous 6 months.
  • Continuous use of oral antiseptics within the last 6 months.
  • Use of systemic antibiotics, corticosteroids, non steroidal anti inflammatory drugs, immunosuppressants, estrogen, estrogen receptor modulators, or medications affecting bone metabolism (e.g., alendronate, calcitonin) within the last 6 months.
  • Presence of systemic conditions that may alter the host response, including: Diabetes mellitus, HIV infection, Down syndrome.
  • Medical conditions requiring antibiotic prophylaxis for dental procedures (e.g., mitral valve prolapse).
  • Known allergy or hypersensitivity to amoxicillin, metronidazole, penicillins, or related compounds.
  • Use of probiotics within the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de São Paulo

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Related Publications (1)

  • Haas AN, Furlaneto F, Gaio EJ, Gomes SC, Palioto DB, Castilho RM, Sanz M, Messora MR. New tendencies in non-surgical periodontal therapy. Braz Oral Res. 2021 Sep 24;35(Supp 2):e095. doi: 10.1590/1807-3107bor-2021.vol35.0095. eCollection 2021.

    PMID: 34586209BACKGROUND

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitis

Interventions

MetronidazoleAnti-Bacterial Agents

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Michel Reis Messora, PhD

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participant allocation will be performed using a computer-generated random number table. The study coordinator will assign patients to one of three groups: Control (SRP), Test 1 (SRP + amoxicillin and metronidazole), and Test 2 (SRP + probiotic), with 20 participants in each group. Participants in Test 1 will receive the antibiotic combination three times daily for 14 days, while participants in Test 2 will receive two probiotic tablets daily for 90 days.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 18, 2026

Study Start

August 22, 2023

Primary Completion

January 30, 2026

Study Completion

February 11, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

The study protocol will be shared as a guide for further research.

Shared Documents
STUDY PROTOCOL
Time Frame
After the publication of the study
Access Criteria
Open access
More information

Locations

BR(1)