Local and Systemic Antimicrobials in Non-surgical Periodontal Therapy

NCT05608564 | Completed Results

• 1 other identifier: 22.10.1980
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The main treatment of every patient with periodontitis is non-surgical periodontal treatment (NSPT) with the ultimate goal to arrest inflammation. Given the biofilm microorganisms associated etiology of the periodontitis, NSPT can be combined with adjunctive antimicrobial therapy. Hence, this randomized clinical trial aims to compare the clinical and microbiological effectiveness and relative expression levels (REL) of proinflammatory cytokines tumor necrosis factor-alpha (TNF-α) and interleukin-17 (IL-17) between local and systemic antibiotics as adjunctive therapy to NSPT in patents with periodontitis stage 3.

Conditions

Periodontitis

Keywords

local antibiotics; systemic antibiotics

Outcome Measures

Primary Outcomes (4)

• Change in Pocket Probing Depth (PPD)

  Pocket probing depth (PPD) was measured using a periodontal probe at 6 sites per tooth, recorded in millimeters (mm), at baseline and at 6-month follow-up. This measure was used to compare outcomes between local and systemic antimicrobial therapies.

  baseline and 6 months follow up

• Change in Clinical Attachment Level (CAL)

  Pocket probing depth (PPD) was measured using a periodontal probe at 6 sites per tooth, recorded in millimeters (mm), at baseline and at 6-month follow-up. This measure was used to compare outcomes between local and systemic antimicrobial therapies.

  baseline and 6 months follow up

• Change in Bleeding On Probing (BOP)

  Bleeding on probing (BOP) was assessed using a periodontal probe at 6 sites around each present tooth during baseline and 6-month follow-up clinical examinations. BOP was recorded as present (1) or absent (0) at each site, and expressed as a percentage (%).

  baseline and 6 months follow up

• Change in Plaque Index (PI)

  Plaque Index (PI) was assessed using a periodontal probe at 6 sites around each present tooth during baseline and 6-month follow-up clinical examinations. BOP was recorded as present (1) or absent (0) at each site, and expressed as a percentage (%).

  baseline and 6 months follow up

Secondary Outcomes (3)

• Changes in Relative Expression Levels of Tumor Necrois Factor Alpha (TNF-α)

  baseline and 6 months follow up

• Change in Total Bacterial Load (TBL)

  baseline and 6 months follow up

• Changes in Relative Expression Levels of IL-17

  baseline and 6 months follow up

Study Arms (2)

Local antibiotic group

EXPERIMENTAL

A combination of Piperacillin and Tazobactam in gel form is applied using a syringe and a flexible blunt needle into the periodontal pockets 24 hours after the non-surgical periodontal therapy. After administration, the dry field should be maintained for 5 minutes and the patient should not rinse the oral cavity for 15 minutes.

Procedure: Piperacillin and Tazobactam in gel form

Systemic antibiotic group

ACTIVE COMPARATOR

Amoxicillin (500mg, 3 times a day, 7 days) and Metronidazole (400mg, 3 times a day, 7 days) per os at the beginning of non-surgical treatment.

Procedure: Amoxicillin and Metronidazole

Interventions

Piperacillin and Tazobactam in gel form PROCEDURE

After non-surgical periodontal treatment, the test group will receive local antibiotics.

Also known as: Gelcide

Local antibiotic group

Amoxicillin and Metronidazole PROCEDURE

After non-surgical periodontal treatment, the control group will receive systemic antibiotics.

Also known as: Amoxicillin and Orvagyl

Systemic antibiotic group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both sexes, 18 - 45 years old
• Willingness to participate in the research, comply with all the study protocols, and sign an informed consent;
• Active periodontitis stage II and III according to the criteria of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions;
• Non-smokers and light smokers (up to 10 cigarettes per day).

You may not qualify if:

• Presence of systemic diseases known to affect the tooth-supporting apparatus and bone metabolism (such as uncontrolled diabetes mellitus, cancer, immunodeficiency, metabolic bone diseases);
• Patients receiving an immunosuppressive, anti-resorptive, or anti-inflammatory therapy;
• Allergy to penicillin;
• Patients who had undergone periodontal therapy within the last 6 months;
• Use of local and/or systemic antimicrobial agents within the last 6 months;
• Use of oral anti-plaque mouthwash at least one month prior to the study;
• Alcohol or drug abuse;
• Pregnancy or lactation.

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

Department of Periodontology, School of Dental Medicine, University of Belgrade

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Piperacillin; Tazobactam; Amoxicillin; Metronidazole

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Penicillanic Acid; Sulfones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Assistant Professor Dr. Iva Milinkovic
• Organization: School Of Dental Medicine, University Of Belgrade, Department of Periodontology and Oral Medicine

iva.milinkovic@gmail.com

+381642041811

Study Officials

• Iva Z Milinkovic, DDS, PhD

  School of Dental Medicine, University of Belgrade, Department of Periodontology and Oral Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: After the non-surgical periodontal treatment, the test group will be treated with local antibiotics, while the control group will be treated with systemic antibiotics. Randomization will be performed using randomization envelopes.

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 8, 2022
• Study Start: January 17, 2023
• Primary Completion: August 10, 2023
• Study Completion: March 11, 2024
• Last Updated: July 17, 2025
• Results First Posted: May 14, 2025

Record last verified: 2025-07

Locations

SE (1)