Local and Systemic Antimicrobials in Non-surgical Periodontal Therapy

Periodontitis Clinical Trial

Official title:

The Impact of Local vs. Systemic Adjuvant Antibiotics During Non-surgical Periodontitis Therapy on Clinical Parameters, Bacterial Count and Cytokine Levels - a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05608564
• Other study ID #: 22.10.1980
• Status: Completed
• Phase: N/A
• Start date: January 17, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: February 2024
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 stages 3.

Description:

Study protocol: This randomized clinical study will include 40 patients diagnosed with periodontitis stages 2 and 3. The investigation will be conducted at the Department of Periodontology and Oral Medicine, at the School of Dental Medicine, University of Belgrade. The laboratory part of the research will be carried out at the Department of Human genetics, at the School of Dental Medicine, University of Belgrade. Patients will be divided into two groups. The test group will consist of 20 patients who will be prescribed a local antibiotic (LA group), while the control group will consist of 20 patients who will be prescribed systemic antibiotic therapy (SA group). The division of patients into groups will be done with randomization envelopes after the diagnostic procedure. Upon clinical examination, clinical periodontal parameters such as periodontal probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), and plaque index (PI) will be recorded for each patient around every tooth. Previous to treatment, subgingival crevicular fluid will be sampled with paper points from periodontal pockets for laboratory analysis. Sampling will be performed as follows: first, a relatively dry working field will be established using paper water rollers and air jets, and then 3 paper points (number 30 - marked in blue) will be applied for 30 seconds in the periodontal pocket area of the selected premolar/molar tooth with a depth of more than 5mm. The procedure will be repeated immediately in the same region, to obtain duplicate samples. After that, the paper points will be placed in Eppendorf tubes and immediately transported to the basic research laboratory, where they will be stored at a temperature of -80 degrees Celsius and where microbiological and molecular analyses will be carried out. After sampling, all patients will undergo a non-surgical phase of periodontal therapy, following a Full-mouth disinfection protocol. Six months after the NSPT, at the follow-up, clinical examination, detection of clinical parameters, and sampling procedure will be repeated. In the LA group, antibiotics will be applied after the NSPT, while in the SA group therapy will be prescribed at the beginning of the treatment. Locally will be applied a combination of piperacillin and tazobactam in gel form (Gelcide ®, Italmed MedTechDental, Florence, Italy) designed for use in the subgingival region. The local antibiotic will be applied into the periodontal pockets, using a syringe and a flexible blunt needle, 24 hours after the NSPT. The administration will be done by quadrants, following the principles of a dry work field, and after application, the dry field should be maintained for 5 minutes. After this procedure, the patient should not rinse the oral cavity for 15 minutes. For systemic use in the SA group, patients will receive a combination of Amoxicillin (Amoxicillin ®, 500mg, 3 times a day, 7 days) and Metronidazole (Orvagyl ®, 400mg, 3 times a day, 7 days) for oral use. Total bacterial count (TBC) and REL of proinflammatory cytokines TNF-α and IL-17 will be detected using the quantitative real-time polymerase chain reaction (qPCR) in a basic research laboratory at the Department of Human genetics, at the School of Dental Medicine, University of Belgrade.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 30, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Both sexes, 18 - 45 years old

2. Willingness to participate in the research, comply with all the study protocols, and sign an informed consent;

3. 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;

4. Non-smokers and light smokers (up to 10 cigarettes per day).

Exclusion Criteria:

1. Presence of systemic diseases known to affect the tooth-supporting apparatus and bone metabolism (such as uncontrolled diabetes mellitus, cancer, immunodeficiency, metabolic bone diseases);

2. Patients receiving an immunosuppressive, anti-resorptive, or anti-inflammatory therapy;

3. Allergy to penicillin;

4. Patients who had undergone periodontal therapy within the last 6 months;

5. Use of local and/or systemic antimicrobial agents within the last 6 months;

6. Use of oral anti-plaque mouthwash at least one month prior to the study;

7. Alcohol or drug abuse;

8. Pregnancy or lactation.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• Piperacillin and Tazobactam in gel form
After non-surgical periodontal treatment, the test group will receive local antibiotics.
• Amoxicillin and Metronidazole
After non-surgical periodontal treatment, the control group will receive systemic antibiotics.

Locations

Country	Name	City	State
Serbia	Department of Periodontology, School of Dental Medicine, University of Belgrade	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local antimicrobials comparable to systemic according to periodontal clinical parameters	A significant change in clinical parameters such as probing depth, clinical attachment level, bleeding on probing, and plaque index is expected after both therapies in a similar matter. It will be detected with the periodontal probe in mm initially and at the follow-up clinical examination 3 months after the initial.	6 months
Primary	Local antimicrobials comparable to systemic according to total bacterial load	Lower total bacteria number after prescription of both systemic and local antibiotics is expected to be proved by analyzing samples of crevicular fluid from pockets using the quantitative real-time polymerase chain reaction (qPCR).	6 months
Primary	Local antimicrobials comparable to systemic according to cytokine levels	Lower relative expression levels of proinflammatory cytokines TNF-a and IL-17 are expected after both systemic and local antibiotics. They will be assessed by analyzing samples of crevicular fluid from pockets detected by using the quantitative real-time polymerase chain reaction (qPCR).	6 months