Effect of Antibiotics on Systemic Inflammation

NCT05115201 | Completed DMC

• 1 other identifier: Manpreet Kaur perio 2021
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Evidence support that pathogenic bacteria are not only responsible for periodontal destruction but also contributes to systemic inflammatory burden either directly or indirectly through increase in pro-inflammatory cytokines. Scaling and root planing (SRP) with or without local antibiotics contributes to reduced systemic inflammation. However, studies also reported insignificant changes in systemic inflammation after SRP. It may be due to incomplete control of periodontal inflammation. Systemic antibiotics proves to beneficial in treatment of severe periodontitis. Systemic antibiotics along with SRP results in improvement of vascular health and systemic inflammation. However, till date no study has been done to evaluate the role of systemic antibiotics as an adjunct to SRP on systemic inflammatory markers. In this randomized control study impact of adjunctive use of systemic antibiotics along with SRP on systemic inflammation would be assessed in periodontitis patients.

Conditions

Periodontitis

Keywords

Anti-bacterial agents; inflammation; periodontitis

Outcome Measures

Primary Outcomes (1)

• High senstivity C-reactive protein (hsCRP)

  For assessing marker of systemic inflammation, serum samples will be collected from venipuncture in antecubital fossa after an overnight fasting.

  2 months

Study Arms (2)

Test group (TG)

EXPERIMENTAL

Patients will be given amoxicillin and metronidazole, 500mg and 400mg respectively (AMX+MTZ) to be taken thrice daily for 7 days, as an adjuvant to scaling and root planing.

Procedure: Scaling and root planing with antibiotics

Control group (CG)

ACTIVE COMPARATOR

Patients will be treated with scaling and root planing only

Procedure: Scaling and root planing only

Interventions

Scaling and root planing with antibiotics PROCEDURE

Patients will be given amoxicillin and metronidazole, 500mg and 400mg respectively (AMX+MTZ) to be taken thrice daily for 7 days, as an adjuvant to scaling and root planing.

Test group (TG)

Scaling and root planing only PROCEDURE

Patients will be treated with scaling and root planing

Control group (CG)

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy individuals
• Presence of at least 20 teeth excluding third molars.
• PH individuals defined as \<10% bleeding sites with probing depths ≤3mm.
• Periodontitis criteria:
• Stage III periodontitis with ≥30% teeth involved and bleeding on probing with \>30% sites involved.

You may not qualify if:

• Confirmed or assumed allergies or hypersensitivity reactions to amoxicillin and/or metronidazole.
• Alcohol consumers.
• History of systemic medication affecting the periodontal conditions, e.g. steroids, immune suppressants, antibiotics, anti-inflammatory drugs, statins, lipid lowering drugs, anti-convulsants, anti-coagulants, anti-hypertensives or any other host modulatory drugs within 6 months of commencing the study.
• Had received any periodontal treatment in the previous 12 months.
• Undergoing or require an extensive dental or orthodontic treatment.
• Pregnant or breastfeeding women.
• Current or former users of tobacco in any form.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Sanjay Tewari

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Periodontitis; Inflammation

Interventions

Tooth Exfoliation; Root Planing; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• MANPREET KAUR, MDS

  Post Graduate Institute of Dental Sciences, Rohtak

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 10, 2021
• Study Start: November 26, 2021
• Primary Completion: June 10, 2022
• Study Completion: June 10, 2022
• Last Updated: December 27, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)