Clinical trial NCT00496847: Efficacy and Safety of PERIOGEN in the Treatment of Periodontal Bone Defect
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intrabony Periodontal Defect
Keywords: rhPDGF,
periodontal disease
Lead sponsor: Virchow Group
Sponsor class: INDUSTRY
First posted: 2007-07-04
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

1. Probing depth ≥7 mm at baseline
2. Presence of ≥4 mm vertical bone defect with at least 1 bony wall after surgical debridement.
3. Adequate keratinized tissue to permit complete tissue coverage of defect.
4. Radiographic base of defect ≥3 mm coronal to the apex of the tooth.

Exclusion Criteria:

1. Failure to maintain adequate oral hygiene (plaque index\>2)
2. Pregnant and lactating women
3. History of oral cancer or HIV
4. Periodontal surgery on treatment-targeted tooth within the last year.
5. Tooth mobility greater than grade II.
6. Study tooth exhibiting a class III furacation defect
7. Localized aggressive periodontitis
8. Radiographic signs of untreated acute infection at the surgical site
9. Recent history of smoking more than 20 cigarettes/day
10. Known allergy to E.coli-derived products
11. Using an investigational therapy within the past 30 days.

Primary outcomes:
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.
timeFrame: 6 months
Secondary outcomes:
measure: 1.Changes in CAL gain, probing depth and gingival recession at 3 and 6 months. 2.Incidence of adverse events.
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: RR Dist
country: India
facility: Sri Sai Dental college of surgery, Vikarabad,
state: Andhra pradesh
Study officials:
affiliation: Sri Sai Dental college of surgery, Vikarabad, RR Dist, AP, India.
name: A Jayakumar, MDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.