Rh-PDGF vs EMD for Treatment of Intra-bony Defects

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNova Southeastern University

About this trial

Treatment of intra-bony defects is challenging and requires extensive knowledge of the etiology, anatomy, occlusion, and available biomaterials that can be used to treat this kind of defects. Patients who received scaling and root planing at the college of dental medicine due to periodontal disease, will be screened for inclusion. Only subjects who showed persistent deep probing depth associated with an intrabony defect will be included and will be randomly allocated to one of two treatment groups. One group will be treated using recombinant human platelet derived growth factor (GEM-21) (test) added to allogenic bone graft, second group will be treated using enamel matrix derivatives (EMD) (control) with allograft. Both groups will be treated using the same surgical protocol. Patients will be followed up for a period of 6 months and 12 months, before getting re-evaluated for assessing the effectiveness of the applied therapies.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age is 18 years old and older

Absence of relevant medical conditions

Availability for 6-month follow-up

Subjects who recently have received scaling and root planing due to periodontal disease

Disqualifiers

Female patients who are pregnant or planning to be pregnant during the period of the study

Heavy smokers (>10 cigarettes a day)

Subjects not willing to comply to the study protocol

Patients with uncontrolled diabetes (HbA1c >7.5)

Trial design

Design model

Parallel

Treatments tested in this trial

  • growth factors to help in regeneration

    Biological/Vaccine

    regenerative therapy

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: recombinant human platelet derived growth factor (rh-PDGF) in combination with bone allograftExperimental treatment 1 intervention
Group B: Enamel matrix derivatives (EMD) in combination with bone allograft.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Attachment Changes

Change in gingival recession and pocket probing depth

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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