NCT03807596

Brief Summary

The present study aimed to assess the adjunctive use of Hyaluronic acid with scaling \& root planing (SRP) in patients with chronic periodontitis \& diabetes mellitus type 2.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

January 15, 2019

Last Update Submit

January 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gain in clinical attachment level

    Gain in clinical attachment level will be measured in millimeter by William's graduated periodontal probe

    12 weeks

Study Arms (2)

SRP group

ACTIVE COMPARATOR

Chronic periodontitis patients with type 2 diabetes mellitus recieved Periodontal treatment in the form of scaling \& root planing (SRP) alone.

Procedure: Scaling & root planning alone

Hyaluronic acid & SRP group

EXPERIMENTAL

Chronic periodontitis \& type 2 diabetes mellitus patients received Periodontal treatment in the form of scaling \& root planing (SRP) with the adjunctive use of hyaluronic acid.

Procedure: Periodontal treatment with Hyaluronic acid associated with SRP

Interventions

In addition to SRP, patients in the test group received adjunct subgingival application of hyaluronic acid in all selected periodontal pockets.

Hyaluronic acid & SRP group

Patients received full-mouth supra- \& sub-gingival SRP with the use of ultrasonic device \& periodontal universal \& Gracey curettes under local anesthesia.

SRP group

Eligibility Criteria

Age38 Months - 56 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients with chronic periodontitis and type 2 diabetes mellitus
  • Minimum of 20 teeth
  • Clinical attachment level (CAL) ≥ 3 mm
  • Probing depth (PD) ≥ 4 mm.

You may not qualify if:

  • Pregnant females
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 12411, Egypt

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Gihane G Madkour, Ass Prof

    Cairo University

    PRINCIPAL INVESTIGATOR

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
Associate Professor

Study Record Dates

First Submitted

January 15, 2019

First Posted

January 17, 2019

Study Start

March 16, 2017

Primary Completion

June 29, 2017

Study Completion

June 29, 2017

Last Updated

January 18, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations