Intrabony Periodontal DefectPhase 3NCT00496847
Efficacy and Safety of PERIOGEN in the Treatment of Periodontal Bone Defect
A Phase 3 study testing PERIOGEN and Beta TCP alone in people with Intrabony Periodontal Defect, run by Virchow Group at 1 site in India.
Trial summary
PERIOGEN, containing rhPDGF and -beta-TCP, promotes gingival healing and corrects periodontal defects. This study will test the safety and efficacy of PERIOGEN in the treatment of periodontal disease Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Intrabony Periodontal Defect
- What is being tested?
- PERIOGEN and Beta TCP alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2007to Aug 2009
- Phase
- Phase 3
- 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 ≥7 mm at baseline
- Presence of ≥4 mm vertical bone defect with at least 1 bony wall after surgical debridement.
- Adequate keratinized tissue to permit complete tissue coverage of defect.
- Radiographic base of defect ≥3 mm coronal to the apex of the tooth.
Who cannot join
- Failure to maintain adequate oral hygiene (plaque index>2)
- Pregnant and lactating women
- History of oral cancer or HIV
- Periodontal surgery on treatment-targeted tooth within the last year.
- Tooth mobility greater than grade II.
- Study tooth exhibiting a class III furacation defect
Show all 11Show fewer
- Localized aggressive periodontitis
- Radiographic signs of untreated acute infection at the surgical site
- Recent history of smoking more than 20 cigarettes/day
- Known allergy to E.coli-derived products
- Using an investigational therapy within the past 30 days.
Trial locations and contacts
1 site in 1 country.
India1 site
Sri Sai Dental college of surgery, Vikarabad,
RR Dist, Andhra Pradesh, 501101
About this study
Official title: Study on the Efficacy and Safety of PERIOGEN in the Treatment of Periodontal Bone Defect - A Double-blind, Controlled, Randomised,Parallel,Multi-centre Study
PERIOGEN, containing rhPDGF and -beta-TCP, promotes gingival healing and corrects periodontal defects. This study will test the safety and efficacy of PERIOGEN in the treatment of periodontal disease
Read the detailed description
Sixty eligible patients with periodontal defect will randomly receive either beta-TCP implantation (control group) or PERIOGEN implantation, containing beta-TCP and rhPDGF (drug group). The specified primary and secondary end points related to efficacy and safety will be assessed during 6 months study period.
- Conditions
- Intrabony Periodontal Defect
- Being tested
- PERIOGEN, Beta TCP alone
- Keywords
- rhPDGF,, periodontal disease
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PERIOGENDrug
Implantation of rhPDGF-BB (0.3 mg/ml) + β-TCP (0.5 g)
Beta TCP aloneDrug
Implantation of β-TCP (0.5 g) alone
| Study group | Role | What they receive |
|---|---|---|
| Drug Group | Experimental | PERIOGEN Receives: Drug: PERIOGEN |
| Control group | Active comparator | Beta TCP alone Receives: Drug: Beta TCP alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Area under curve (AUC) of clinical attachment level (CAL) gain (0-24 weeks) 2.Extent of linear bone growth (LBG) and percentage of bone fill (%BF) at 6 months.
Measured: 6 months
Secondary outcomes (1)
1.Changes in CAL gain, probing depth and gingival recession at 3 and 6 months. 2.Incidence of adverse events.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionAug 2008
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrabony Periodontal DefectStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virchow Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- A Jayakumar, MDS, Principal investigator, Sri Sai Dental college of surgery, Vikarabad, RR Dist, AP, India.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496847
- Sponsor's protocol ID
- VB023/07
- Status last verified
- Nov 2009
- First submitted
- 3 Jul 2007
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jayakumar A, Rajababu P, Rohini S, Butchibabu K, Naveen A, Reddy PK, Vidyasagar S, Satyanarayana D, Pavan Kumar S. Multi-centre, randomized clinical trial on the efficacy and safety of recombinant human platelet-derived growth factor with beta-tricalcium phosphate in human intra-osseous periodontal defects. J Clin Periodontol. 2011 Feb;38(2):163-72. doi: 10.1111/j.1600-051X.2010.01639.x. Epub 2010 Dec 6.
PubMed 21133980
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of PERIOGEN in the Treatment of Periodontal Bone Defect - A Double-blind, Controlled, Randomised,Parallel,Multi-centre Study
- ClinicalTrials.gov ID
- NCT00496847
- Acronym / sponsor ID
- VB023/07
- Conditions
- Intrabony Periodontal Defect
- Keywords
- rhPDGF,, periodontal disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Virchow GroupIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 4 Jul 2007 (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.
PERIOGEN, containing rhPDGF and -beta-TCP, promotes gingival healing and corrects periodontal defects. This study will test the safety and efficacy of PERIOGEN in the treatment of periodontal disease
Detailed description
Sixty eligible patients with periodontal defect will randomly receive either beta-TCP implantation (control group) or PERIOGEN implantation, containing beta-TCP and rhPDGF (drug group). The specified primary and secondary end points related to efficacy and safety will be assessed during 6 months study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Group | Experimental | Drug: PERIOGENPERIOGEN |
| Control group | Active comparator | Drug: Beta TCP aloneBeta TCP alone |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Probing depth ≥7 mm at baseline
- Presence of ≥4 mm vertical bone defect with at least 1 bony wall after surgical debridement.
- Adequate keratinized tissue to permit complete tissue coverage of defect.
- Radiographic base of defect ≥3 mm coronal to the apex of the tooth.
Key exclusion criteria (11 listed)
- Failure to maintain adequate oral hygiene (plaque index>2)
- Pregnant and lactating women
- History of oral cancer or HIV
- Periodontal surgery on treatment-targeted tooth within the last year.
- Tooth mobility greater than grade II.
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 |
|---|---|---|
| PERIOGENImplantation of rhPDGF-BB (0.3 mg/ml) + β-TCP (0.5 g) | Drug | Drug Group |
| Beta TCP aloneImplantation of β-TCP (0.5 g) alone | Drug | Control group |
Primary outcome
1.Area under curve (AUC) of clinical attachment level (CAL) gain (0-24 weeks) 2.Extent of linear bone growth (LBG) and percentage of bone fill (%BF) at 6 months.
Time frame: 6 months
1 secondary outcome
1.Changes in CAL gain, probing depth and gingival recession at 3 and 6 months. 2.Incidence of adverse events.
Time frame: 3 and 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 16 Dec 2014.
- Derived from this study: PubMed 21133980Jayakumar A, Rajababu P, Rohini S, Butchibabu K, Naveen A, Reddy PK, Vidyasagar S, Satyanarayana D, Pavan Kumar S. Multi-centre, randomized clinical trial on the efficacy and safety of recombinant human platelet-derived growth factor with beta-tricalcium phosphate in human intra-osseous periodontal defects. J Clin Periodontol. 2011 Feb;38(2):163-72. doi: 10.1111/j.1600-051X.2010.01639.x. Epub 2010 Dec 6.
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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.
A Jayakumar, MDS principal investigator
Sri Sai Dental college of surgery, Vikarabad, RR Dist, AP, India.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PERIOGEN and Beta TCP alone in people with Intrabony Periodontal Defect, run by Virchow Group at 1 site in India.
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 4 inclusion and 11 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 16 Dec 2014. 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 India. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
1.Area under curve (AUC) of clinical attachment level (CAL) gain (0-24 weeks) 2.Extent of linear bone growth (LBG) and percentage of bone fill (%BF) at 6 months. (time frame: 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 NCT00496847, which also lists 1 linked publication.
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 16 Dec 2014.