NCT02218515

Brief Summary

The present study aimed to evaluate the effects of enamel matrix derivatives either alone or combined with autogenous bone graft applied to intrabony defects in chronic periodontitis patients on clinical/radiographic parameters and gingival crevicular fluid transforming growth factor-β1 level and, to compare with open flap debridement. Our hypothesis is to test whether the use of autogenous bone graft and enamel matrix derivative combination in the treatment of intrabony periodontal defects enhance the clinical, radiographic and biochemical parameters in comparison to the use of open flap debridement alone.

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 phase_4

Timeline
Completed

Started Sep 2010

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

September 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
Last Updated

August 18, 2014

Status Verified

August 1, 2014

Enrollment Period

2 years

First QC Date

August 11, 2014

Last Update Submit

August 14, 2014

Conditions

Periodontal Bone LossChronic Periodontitis

Keywords

Autogenous bone graftChronic periodontitisEnamel matrix derivativesGingival crevicular fluidPeriodontal flap surgery

Outcome Measures

Primary Outcomes (1)

  • Attachment Gain

    6 months after surgery

Secondary Outcomes (1)

  • Gingival crevicular fluid TGF-β1 level

    1 week, 2 weeks, 4 weeks, 12 weeks and 72 weeks after surgery

Other Outcomes (7)

  • Plaque index

    Baseline and 6 months post-surgery.

  • Gingival index

    Baseline and 6 months post-surgery

  • Bleeding on probing

    Baseline and 6 months post-surgery

  • +4 more other outcomes

Study Arms (3)

Open Flap Debridement

OTHER

Open Flap Debridement (Control Group)

Procedure: Open Flap Debridement

Enamel Matrix Derivative

EXPERIMENTAL

Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)

Biological: EmdogainⓇ(Enamel Matrix Derivative)

Enamel Matrix Derivative+Autogenous Bone

EXPERIMENTAL

Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone

Biological: EmdogainⓇEnamel Matrix Derivative+Autogenous Bone

Interventions

Open Flap DebridementPROCEDURE

Open Flap Debridement (Control Group)

Open Flap Debridement
EmdogainⓇ(Enamel Matrix Derivative)BIOLOGICAL

Open Flap Debridement+Enamel Matrix Derivative

Enamel Matrix Derivative
EmdogainⓇEnamel Matrix Derivative+Autogenous BoneBIOLOGICAL

Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone

Enamel Matrix Derivative+Autogenous Bone

Eligibility Criteria

Age32 Years - 57 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • (a) no systemic diseases as diabetes mellitus or cardiovascular diseases that contraindicated periodontal surgery and could influence the outcome of the therapy; (b) no smoking (c) no medications affecting periodontal tissues; (d) no pregnancy or lactation; (e) a good level of oral hygiene (plaque index \< 1, and full mouth bleeding on probing score \<20% after initial periodontal treatment), (f) compliance with the maintenance programme and (g) presence of at least one intra-bony defect with a probing depth ≥6 mm, radiographic depth of the defect ≥3 mm as detected on the radiographs.

You may not qualify if:

  • (a) pregnancy or lactating, (b) required an antibiotic premedication, (c) received antibiotic treatment in the previous 6 months, (d) smokers, (e) whose tooth had inadequate amount of attached keratinized gingiva (\<1mm)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Faculty of Dentistry, Department of Periodontology

Istanbul, Şişli/Nişantaşı, 34365, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alveolar Bone LossChronic Periodontitis

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ömer Birkan Ağralı, Dr.

    Marmara University Faculty of Dentistry, Department of Periodontology

    PRINCIPAL INVESTIGATOR

  • Bahar Kuru, Prof. Dr.

    Marmara University, Faculty of Dentistry, Department of Periodontology

    STUDY CHAIR

  • Leyla Kuru, Prof. Dr.

    Marmara University, Faculty of Dentistry, Department of Periodontology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

August 11, 2014

First Posted

August 18, 2014

Study Start

September 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

August 18, 2014

Record last verified: 2014-08

Locations

TU(1)