NCT00519155

Brief Summary

The purpose of the study is to gain experience of safety and efficacy with MD05 in man in alveolar bone regeneration.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

April 23, 2008

Status Verified

April 1, 2008

Enrollment Period

1.3 years

First QC Date

August 21, 2007

Last Update Submit

April 21, 2008

Conditions

Alveolar Bone LossPeriodontal Bone Loss

Outcome Measures

Primary Outcomes (1)

  • Evidence of regeneration of alveolar bone.

    October 2008

Secondary Outcomes (1)

  • Evidence of uncompromised healing.

    October 2008

Study Arms (2)

1

EXPERIMENTAL

Open flap debridement + MD05

Drug: MD05 and open flap debridement

2

ACTIVE COMPARATOR

Open flap debridement

Procedure: Open flap debridement

Interventions

MD05 and open flap debridementDRUG

recombinant human GDF-5 coated onto ß-tricalcium phosphate

1
Open flap debridementPROCEDURE

Open flap debridement alone

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring extraction of teeth with advanced intrabony periodontal defects at single rooted teeth without root concavities/furrows located in the maxilla and mandible (maxillary/mandibular premolars, maxillary incisors; presurgery probing depth ≥ 6 mm, intrasurgery defect depth ≥ 4 mm) or located the mesial or distal aspect of mandibular molar teeth without adjacent teeth (excluding defects also involving the furcation area).
  • Teeth to be treated must be scheduled for extraction in a treatment plan established by clinicians unrelated to the study.
  • Male and female patients, aged 18 - 75 years
  • Patients must be non-smokers
  • Female patients must be infertile (either sterilized or postmenopausal). If a patient's menopausal status at screening is uncertain, levels of follicle stimulating hormone (FSH) should be determined. Patients with an FSH level \> 25 IU/l and absence of menstrual bleeding \> 6 months will satisfy the definition of postmenopausal status.
  • Patient must provide written informed consent

You may not qualify if:

  • Women of childbearing potential, pregnant or lactating women
  • Participation in another clinical study within 30 days prior to study start
  • Previous participation in this study
  • Legal incompetence or restricted legal competence
  • Alcoholism, drug dependency, smoking
  • Acute or chronic infection at the application site
  • Known infection with HIV, HBV, or HCV
  • Severe allergic rhinitis which requires permanent medication
  • Known intolerance of or hypersensitivity to ß-TCP or rhGDF?5
  • Presence of local or systemic malignant disease or history of local or systemic malignant disease in the past 5 years.
  • Patients requiring chemo- or radiotherapy
  • Previous or current radiotherapy of the head
  • Chronic liver disorder (AST and/or ALT over 2 times upper limit of normal)
  • Impaired renal function (creatinine over 1.5 times upper limit of normal)
  • Uncontrolled insulin-dependent diabetes mellitus (HbA1c \> 7%)
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Periodontology, Semmelweis University Budapest

Budapest, Budapest, 1085, Hungary

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Anton Sculean, Prof.

    Department of Periodontology; Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 21, 2007

First Posted

August 22, 2007

Study Start

July 1, 2007

Primary Completion

October 1, 2008

Study Completion

November 1, 2008

Last Updated

April 23, 2008

Record last verified: 2008-04

Locations

HU(1)