Efficacy and Safety of PERIOGEN in the Treatment of Periodontal Bone Defect

NCT00496847 | Completed Phase 3

• 1 other identifier: VB023/07
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Intrabony Periodontal Defect

Keywords

rhPDGF,; periodontal disease

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  3 and 6 months

Study Arms (2)

Drug Group

EXPERIMENTAL

PERIOGEN

Drug: PERIOGEN

Control group

ACTIVE COMPARATOR

Beta TCP alone

Drug: Beta TCP alone

Interventions

PERIOGEN DRUG

Implantation of rhPDGF-BB (0.3 mg/ml) + β-TCP (0.5 g)

Drug Group

Beta TCP alone DRUG

Implantation of β-TCP (0.5 g) alone

Control group

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Virchow Group: lead

Study Sites (1)

Sri Sai Dental college of surgery, Vikarabad,

RR Dist, Andhra Pradesh, 501101, India

Location

Related Publications (1)

• 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.

  PMID: 21133980 DERIVED

MeSH Terms

Conditions

Periodontal Diseases

Interventions

beta-tricalcium phosphate

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• A Jayakumar, MDS

  Sri Sai Dental college of surgery, Vikarabad, RR Dist, AP, India.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: August 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2009
• Last Updated: December 16, 2014

Record last verified: 2009-11

Locations

IN (1)