NCT02735837

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_2

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2016

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

March 30, 2016

Last Update Submit

July 2, 2019

Conditions

Diabetes Mellitus With Periodontal Disease

Outcome Measures

Primary Outcomes (1)

  • Periodontal pocket

    Periodontal probe

    15 days

Secondary Outcomes (1)

  • glycated hemoglobin (HbA1c)

    3 months

Study Arms (2)

doxycycline gel

ACTIVE COMPARATOR

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

Drug: Doxycycline Group

placebo gel

PLACEBO COMPARATOR

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

Drug: placebo topical gel

Interventions

Doxycycline GroupDRUG

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

Also known as: Doxycycline 3% topical gel, Group A
doxycycline gel
placebo topical gelDRUG

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

Also known as: Group B
placebo gel

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diabetes mellitus type II (at least 3 months before diagnosis, and A fasting blood sugar level of more than 125 mg/dl) and has periodontal disease is a chronic moderate (has a clinical attachment level of 3-4 mm) peritonitis
  • Minimum of 16 natural teeth, and no periodontal treatment in the prior 6 months, - Had a glycated α hemoglobin (HbA1c) value between 7- 9 percent at screening
  • Had reported no changes in diabetes medications within the last 3 months were in the care of a physician for their diabetes.

You may not qualify if:

  • Pregnancy or lactation
  • History of allergy to drugs used in the study
  • Smoking
  • Diabetes-related emergency within 30 days ago
  • Use of nonsteroidal anti-inflammatory drugs
  • Or taking low dose daily aspirin (75-325 mg)\\
  • Use of immunosuppressive medications; antibiotic use
  • Dialysis
  • Risk of bleeding complications
  • The type of disease periodontal (Aggressive)
  • A history of periodontal treatment in the previous 6 months
  • Orthodontic treatment
  • Using the removal prostheses
  • Extensive dental caries
  • Dental abscesses or infections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

DoxycyclineGels

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The effect of non-surgical periodontal therapy with adjunctive topical doxycycline gel on HbA1c in patients with type 2 diabetes mellitus (DM).

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 13, 2016

Study Start

January 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share