Comparative Evaluation of Collagen Sponge with recombinant bone morphogenic protein 2 for Alveolar Ridge Preservation: A Pilot Clinical Study

Authors
Category Primary study
Registry of TrialsThai Clinical Trials Registry
Year 2024
INTERVENTION: Absorbable collagen sponge(ACS)/rhBMP‐2,No treatment/ Standard of care Experimental Drug,No Intervention No treatment Local anesthesia (2% lidocaine with epinephrine 1:105 in a quantity, 1‐2 cartridges), was administered, and the tooth was atraumatic extracted. The extraction wound was cleaned with 0.9% NSS. In the experimental group, Absorbable collagen sponge(ACS) soaked with a rhBMP‐2 solution (1.5 mg/mL) was inserted 1 mm below the marginal bone, followed by a figure‐of‐eight stitch using 4‐0 absorbable sutures (Vicryl 4‐0; Ethicon, Norderstedt, Germany). Both groups followed the same postoperative care regimen: postoperative antibiotics (amoxicillin 500 mg) were prescribed every 8 hours for 5 days and ibuprofen 400 mg every 8 hours for 5 days. The antiseptic mouthwash with 0.12% chlorhexidine gluconate was used for rinsing 2 times a day for 1 week. Sutures were removed after 2 weeks. ,Local anesthesia (2% lidocaine with epinephrine 1:105 in a quantity, 1‐2 cartridges), was administered, and the tooth was atraumatic extracted. The extraction wound was cleaned with 0.9% NSS. In the control group, the socket was left empty and no ridge preservation. Both groups followed the same postoperative care regimen. CONDITION: Alveolar ridge preservation, rhBMP‐2, Collagen. Enrolled the healthy patient who need to extract the single‐tooth extraction in the premolar tooth due to unrestorable (caries, fracture, or orthodontic treatment) with an intact buccal bone plate (more than 50%) ; Alveolar ridge preservation, rhBMP‐2, Collagen. PRIMARY OUTCOME: Bone reduction 12 weeks Mean difference bone reduction SECONDARY OUTCOME: Clinical evaluation 12 weeks Soft tissue healing INCLUSION CRITERIA: The healthy patient who need to extract the single‐tooth extraction in the premolar tooth due to unrestorable (caries, fracture, or orthodontic treatment) with an intact buccal bone plate (more than 50% Healthy adults patient (20 years or older) and able to sign an informed consent form. All extraction sites have a keratinized gingival tissue in a minimum width of 2 mm
Epistemonikos ID: c0963138d27fc2c620bbb7fa742495628d51893b
First added on: Apr 02, 2025