Periodontal Diseases
Conditions
Keywords
Periodontal Regeneration, Grow Factors, intraosseous defects
Brief summary
Growth factors are defined as small proteins that trigger a cellular response after binding to cell receptors; Tissue engineering is now clinically applicable in a commercially available system involving the use of recombinant human platelet-derived growth factor. The objective of this study is to evaluate clinical and radiographic parameters in bone defects treated with platelet-derived growth factor in combination with allograft. Our hypothesis: Defects treated with DFDBA and rhPDGF-BB have better clinically and radiographic results that the defects treated with DFDBA and saline solution.
Detailed description
The study will be performed in 30 periodontal defects of 2 and 3 walls. The experimental group will consist of DFDBA placement with rhPDGF-BB and control DFDBA with saline solution. The clinical parameters recorded were Probing deep (PD), clinical attachment level (CAL), recession depth, Index of bleeding and plaque at baseline and at six months. Our universe is patients with periodontitis attending at the clinical in Periodontics at the Autonomous University of Nuevo Leon (UANL) School of Dentistry.
Interventions
COMBINATION_PRODUCTAllograft and rHPDGF-BB
At this intervention the periodontal defect will be treated with allograft and rHPDGF-BB (GEM21)
COMBINATION_PRODUCTAllograft and Saline solution
This will be used as the control group
Sponsors
LifeNet Health
Lynch Biologics LLC
Universidad Autonoma de Nuevo Leon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
It is a triple-blind study, where the operator, the investigator and the statistician have no knowledge of the material placed in the procedure.
Intervention model description
The study was conducted in two groups with control and experimental groups which were evaluated during a period of six months with monthly evaluation until the results were obtained.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of periodontitis * Infrabony defects of 2 walls, 3 walls and combined defects * Patients ASA (American Society of Anesthesiologists) I and II * Patients who smoke less than 10 cigarettes
Exclusion criteria
* Patients undergoing bisphosphonate therapy * Furcation defects * Patients with evidence of blood dyscrasias. * Pregnant patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing depth | Initial and six months after surgery | The distance from free gingival margin to sulcus depth, ≥4 millimeters (mm) |
| Bleeding on probing | Initial and six months after surgery | Method to asses gingival inflammation. Gingival health is defined as \< 10% bleeding sites |
| Gingival Recession | Initial and six months after surgery | The distance from the soft tissue (gingiva or alveolar mucosa) margin to cemento-enamel junction, ≥1 millimeters (mm) |
| Clinical Attachment Level | Initial and six months after surgery | The distance from the cemento-enamel junction to the tip of a periodontal probe during periodontal diagnostic probing, ≥2 mm (millimeters) |
| Gingival Phenotype | Initial and six months after surgery | Gingival phenotype is determined by gingival thickness and keratinized tissue width. Probe visible: thin (≤1 mm). Probe not visible: thick (\>1mm). |
| Plaque control record | Initial and six months after surgery | O'Leary index is used for assessing oral hygiene skills of the patient |
| Radiographic Measurements | Initial and six months after surgery | Cemento-enamel junction (CEJ)-Defect Base (DB): The distance of the cementoenamel junction at the base of the defect. Cemento-enamel junction (CEJ)-Bone crest (BC): The distance of the cemento-enamel junction to the crest of bone. Cemento-enamel junction (CEJ)- Root apex (RA): The distance of the cemento-enamel junction to root apex. Lineal Bone Growth (LBG) = CEJ to base of defect at baseline - CEJ to base of defect at 6 months. %BF: Percent bone fill was calculated by dividing LBG by the depth of the original bone defect |
Countries
Mexico
Contacts
Primary ContactJesus I Rodriguez Pulido, Dr
Backup ContactJessica P Arredondo Muñoz, Dr
Outcome results
None listed