NCT06378112

Extraction Socket Augmentation. A Clinical Study

Extraction Socket Augmentation Using GTO vs. Apatos. A Randomized Controlled Clinical Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Universidad de Granada · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Extraction socket preservation is defined as alveolar ridge preservation within the bone envelope remaining after tooth extraction, meanwhile ridge augmentation is defined as increasing the volume of alveolar ridge beyond the bony envelope at the time of tooth extraction. It is recommended to use in cases where extraction socket anatomy is intact. In contrast definition "extraction socket augmentation" defines alveolar ridge restoration when bony walls of the socket are partly or completely lost. In the case of severe loss (\> 50%) of the buccal bone plate, preservation of hard tissue with a prolonged healing time before implant placement has been suggested. The null hypothesis of this experimental work states that: (i) the two different bone graft materials gained the same amount of bone following horizontal ridge augmentation procedure; (i) the two different bone graft materials exhibit similar histological and histomorphometric results Therefore, the main purpose of the current study is to compare two different biomaterials using guided bone regeneration procedures in the ridge preservation/ augmentation (hard-tissue preservation).

Detailed description

Patients needing teeth extraction and unitary implant placement will be recruited at the Dental School of the University of Granada (Máster de Cirugía Bucal). Two study groups will be stated: * Group 1 (test group): Guided bone regeneration procedure with GTO® as bone graft and soft collagenated cortical membrane (OsteoBiol® Lamina; Tecnoss srl) as graft stabilizer. * Group 2 (control): Guided bone regeneration procedure with Apatos Mix® cortico-cancellous heterologous bone mix (OsteoBiol®; Tecnoss srl) as bone graft and soft collagenated cortical membrane (OsteoBiol® Lamina; Tecnoss srl) as graft stabilizer. All employed Materials are commercially available and are completely approved to be used in humans. They are currently being used in dental practice in Europe, U.S.A. and many other countries. Eurofins Product Testing Italy S.r.l certifies that the manufacturer's full quality assurance system is compliant with Annex II of 93/42/EEC Medical Devices Directive and subsequent amenaments and upgrades (Certificate No. EPT0477.MDD.19/3209.1).

Conditions

• Edentulous Alveolar Ridge With Labial Resorption

Interventions

Type	Name	Description
DRUG	GTO®	After teeth extraction, a guided bone regeneration procedure will be performed using a bone graft and a soft collagenated cortical membrane as graft stabilizer. Implant placement surgery will also be performed.

Timeline

• Start date: 2022-05-20
• Primary completion: 2025-01-15
• Completion: 2025-12-30
• First posted: 2024-04-22
• Last updated: 2024-04-22

Locations

1 site across 1 country: Spain