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The Effect of Topical Doxycycline Gel on HbA1c in Patients With Type 2 Diabetes Mellitus(DM) ®

NCT02735837 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-07-05

No results posted yet for this study

Summary

Aim:

The purpose of this study is to investigate the effect of nonsurgical periodontal therapy plus subgingivally doxycycline gel 3% on glycemic control in type 2 diabetes mellitus (type 2 DM) patients who have periodontitis.

Materials and methods:

A total of 24 type 2 DM patients with periodontitis will be selected for the study, and randomly divided into two equal groups,who are at least 35 years of age and 16 teeth and type II diabetes are (at least the last 3 months of diagnosis of diabetes and its FBS More than 110 have), and also with periodontal disease are chronic moderate (at least in three areas Attachment level to a depth of 3-4 mm maxillary or mandibular been confirmed by clinical examination and radiographic signs are being); Takes place. The initial HbA1c Patients should be between 7-9 percent over the past three months has changed his medication also found the necessary explanations on how to do that consent, Plaque index (PI) by Loe \& Silness, bleeding on probing (BOP) based on Carter and Barnes (if any bleeding number 1 and its absence is 0), probing depth (PD) and clinical attachment levels (CAL) were recorded. "Group 1": (12 patients) was treated with oral hygiene instruction, scaling and root planing, and doxycycline gel for 15 days; and "Group 2": (12 patients) has the same treatment but with placebo gel, After 12 weeks their periodontal condition and Fasting blood sugar (FBS), glycated hemoglobin (HbA1c) level, will be reevaluated.

Conditions

  • Diabetes Mellitus With Periodontal Disease

Interventions

DRUG

Doxycycline Group

Doxycycline 3% topical gel was put into the periodontal pocket using an insulin syringe

DRUG

placebo topical gel

placebo topical gel was put into the periodontal pocket using an insulin syringe

Sponsors & Collaborators

  • Amirhossein Farahmand

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-03-31
Completion
2016-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02735837 on ClinicalTrials.gov