PeriodontitisNCT01530126
Platelet Derived Growth Factor Stimulates Bone Fill and Rate of Attachment Level Gain
A study testing B-TCP + 0.3 mg/ml rhPDGF-BB in buffer, B-TCP + 1.0 mg/ml rhPDGF-BB in buffer and B-TCP +buffer in people with Periodontitis, run by University of Michigan at 1 site in United States.
Trial summary
The aim of the study was to evaluate the safety and effectiveness of Platelet Derived Growth Factor (PDGF) mixed with b tricalcium phosphate (BTCP) for the treatment of advanced periodontal osseous defects at 6 months of healing. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- B-TCP + 0.3 mg/ml rhPDGF-BB in buffer, B-TCP + 1.0 mg/ml rhPDGF-BB in buffer and B-TCP +buffer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Jan 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- probing depth of 7mm or greater at baseline
- following debridement, 4mm or greater vertical bone defect depth with at least one intact bony wall
- sufficient keratinized tissue to allow complete tissue coverage of the defect
- a radiographic base of the defect at least 3mm coronal to the apex of the tooth
- no evidence of localized aggressive periodontitis
- smoke less than 1 pack of cigarettes per day
Who cannot join
- failure to maintain adequate oral hygiene
- pregnant women or women intending to become pregnant
- history of oral cancer within last 6 months or HIV
- history within last year of periodontal surgery on study tooth
- study tooth mobility greater than 2
- study tooth exhibiting a class 3 furcation defect
Show all 10Show fewer
- signs of untreated acute infection at the surgical site, apical pathology, root fracture, severe root irregularities, cemental pearls, cementoenamel junction (CEJ) projections not easily removed, untreated carious lesions at the CEJ or on the root surface, subgingival restorations or restorations with open margins at or below CEJ
- history within 6 months of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking, or more than 20 cigarettes a day
- allergy to yeast derived products
- investigational therapy within 30 days of surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
About this study
The aim of the study was to evaluate the safety and effectiveness of Platelet Derived Growth Factor (PDGF) mixed with b tricalcium phosphate (BTCP) for the treatment of advanced periodontal osseous defects at 6 months of healing.
Read the detailed description
This triple blind, prospective and parallel arm trial was conducted in subjects requiring surgical treatment of a periodontal osseous defect.
- Conditions
- Periodontitis
- Being tested
- B-TCP + 0.3 mg/ml rhPDGF-BB in buffer, B-TCP + 1.0 mg/ml rhPDGF-BB in buffer, B-TCP +buffer
- Keywords
- periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-TCP + 0.3 mg/ml rhPDGF-BB in bufferBiological
B-TCP mixed with sodium acetate buffer and 0.3 mg/ml rhPDGF-BB and placed into osseous defect once at baseline visit.
B-TCP + 1.0 mg/ml rhPDGF-BB in bufferBiological
B-TCP mixed with sodium acetate buffer and 1.0 mg/ml rhPDGF-BB and placed into osseous defect once at baseline visit.
B-TCP +bufferBiological
B-TCP mixed with sodium acetate buffer and placed into osseous defect once at baseline visit.
| Study group | Role | What they receive |
|---|---|---|
| B-TCP +buffer | Active comparator | Administration of synthetic beta-tricalcium phosphate (B-TCP) mixed in sodium acetate buffer only. Receives: Biological: B-TCP +buffer |
| B-TCP + 0.3 mg/ml rhPDGF-BB in buffer | Experimental | Administration of synthetic beta-tricalcium phosphate (B-TCP) mixed with purified 0.3 mg/ml recombinant human platelet-derived growth factor (rhPDGF-BB) in sodium acetate buffer. Receives: Biological: B-TCP + 0.3 mg/ml rhPDGF-BB in buffer |
| B-TCP + 1.0 mg/ml rhPDGF-BB in buffer | Experimental | Administration of synthetic beta-tricalcium phosphate (B-TCP) mixed with purified 1.0 mg/ml recombinant human platelet-derived growth factor (rhPDGF-BB) in sodium acetate buffer. Receives: Biological: B-TCP + 1.0 mg/ml rhPDGF-BB in buffer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of CAL Gain
Measurements for the rate of clinical attachment levels (CAL)
Measured: Baseline to 6 months
Secondary outcomes (1)
Change in Gingival Recession (GR)
Measurements in changes of gingival recession (GR)
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startJan 2000
- Primary completionJan 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Giannobile, University of Michigan
- Investigators
- William Giannobile, DDS, DMedSc, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530126
- Sponsor's protocol ID
- 2005 - PDGF
- Status last verified
- Jan 2016
- First submitted
- 6 Feb 2012
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Nevins M, Giannobile WV, McGuire MK, Kao RT, Mellonig JT, Hinrichs JE, McAllister BS, Murphy KS, McClain PK, Nevins ML, Paquette DW, Han TJ, Reddy MS, Lavin PT, Genco RJ, Lynch SE. Platelet-derived growth factor stimulates bone fill and rate of attachment level gain: results of a large multicenter randomized controlled trial. J Periodontol. 2005 Dec;76(12):2205-15. doi: 10.1902/jop.2005.76.12.2205.
PubMed 16332231Nevins M, Kao RT, McGuire MK, McClain PK, Hinrichs JE, McAllister BS, Reddy MS, Nevins ML, Genco RJ, Lynch SE, Giannobile WV. Platelet-derived growth factor promotes periodontal regeneration in localized osseous defects: 36-month extension results from a randomized, controlled, double-masked clinical trial. J Periodontol. 2013 Apr;84(4):456-64. doi: 10.1902/jop.2012.120141. Epub 2012 May 21.
PubMed 22612364
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Derived Growth Factor Stimulates Bone Fill and Rate of Attachment Level Gain
- ClinicalTrials.gov ID
- NCT01530126
- Acronym / sponsor ID
- 2005 - PDGF
- Conditions
- Periodontitis
- Keywords
- periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study was to evaluate the safety and effectiveness of Platelet Derived Growth Factor (PDGF) mixed with b tricalcium phosphate (BTCP) for the treatment of advanced periodontal osseous defects at 6 months of healing.
Detailed description
This triple blind, prospective and parallel arm trial was conducted in subjects requiring surgical treatment of a periodontal osseous defect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B-TCP +buffer | Active comparator | Biological: B-TCP +bufferAdministration of synthetic beta-tricalcium phosphate (B-TCP) mixed in sodium acetate buffer only. |
| B-TCP + 0.3 mg/ml rhPDGF-BB in buffer | Experimental | Biological: B-TCP + 0.3 mg/ml rhPDGF-BB in bufferAdministration of synthetic beta-tricalcium phosphate (B-TCP) mixed with purified 0.3 mg/ml recombinant human platelet-derived growth factor (rhPDGF-BB) in sodium acetate buffer. |
| B-TCP + 1.0 mg/ml rhPDGF-BB in buffer | Experimental | Biological: B-TCP + 1.0 mg/ml rhPDGF-BB in bufferAdministration of synthetic beta-tricalcium phosphate (B-TCP) mixed with purified 1.0 mg/ml recombinant human platelet-derived growth factor (rhPDGF-BB) in sodium acetate buffer. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- probing depth of 7mm or greater at baseline
- following debridement, 4mm or greater vertical bone defect depth with at least one intact bony wall
- sufficient keratinized tissue to allow complete tissue coverage of the defect
- a radiographic base of the defect at least 3mm coronal to the apex of the tooth
- no evidence of localized aggressive periodontitis
Key exclusion criteria (10 listed)
- failure to maintain adequate oral hygiene
- pregnant women or women intending to become pregnant
- history of oral cancer within last 6 months or HIV
- history within last year of periodontal surgery on study tooth
- study tooth mobility greater than 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B-TCP + 0.3 mg/ml rhPDGF-BB in bufferB-TCP mixed with sodium acetate buffer and 0.3 mg/ml rhPDGF-BB and placed into osseous defect once at baseline visit. | Biological | B-TCP + 0.3 mg/ml rhPDGF-BB in buffer |
| B-TCP + 1.0 mg/ml rhPDGF-BB in bufferB-TCP mixed with sodium acetate buffer and 1.0 mg/ml rhPDGF-BB and placed into osseous defect once at baseline visit. | Biological | B-TCP + 1.0 mg/ml rhPDGF-BB in buffer |
| B-TCP +bufferB-TCP mixed with sodium acetate buffer and placed into osseous defect once at baseline visit. | Biological | B-TCP +buffer |
Primary outcome
Rate of CAL Gain
Time frame: Baseline to 6 months
Measurements for the rate of clinical attachment levels (CAL)
1 secondary outcome
Change in Gingival Recession (GR)
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Results publication: PubMed 16332231Nevins M, Giannobile WV, McGuire MK, Kao RT, Mellonig JT, Hinrichs JE, McAllister BS, Murphy KS, McClain PK, Nevins ML, Paquette DW, Han TJ, Reddy MS, Lavin PT, Genco RJ, Lynch SE. Platelet-derived growth factor stimulates bone fill and rate of attachment level gain: results of a large multicenter randomized controlled trial. J Periodontol. 2005 Dec;76(12):2205-15. doi: 10.1902/jop.2005.76.12.2205.
- Results publication: PubMed 22612364Nevins M, Kao RT, McGuire MK, McClain PK, Hinrichs JE, McAllister BS, Reddy MS, Nevins ML, Genco RJ, Lynch SE, Giannobile WV. Platelet-derived growth factor promotes periodontal regeneration in localized osseous defects: 36-month extension results from a randomized, controlled, double-masked clinical trial. J Periodontol. 2013 Apr;84(4):456-64. doi: 10.1902/jop.2012.120141. Epub 2012 May 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Giannobile, DDS, DMedSc principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-TCP + 0.3 mg/ml rhPDGF-BB in buffer, B-TCP + 1.0 mg/ml rhPDGF-BB in buffer and B-TCP +buffer in people with Periodontitis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of CAL Gain (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01530126, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.