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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).
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (test group) | Experimental | Guided bone regeneration procedure with GTO® as bone graft and soft collagenated cortical membrane (OsteoBiol® Lamina; Tecnoss srl) as graft stabilizer. |
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| Group 2 (control) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GTO® | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dimensional bone changes | Cone Beam Computed Tomography (CBCT) scans will be performed to each patient to evaluate the dimensional bone changes (height and width): one scan will be made immediately after regenerative surgery, and a second scan will be performed after a postoperative healing period of 6 months (prior to implant placement). Dimensional bone changes will be assessed superimposing and aligning the T0 (after regenerative surgery) and T1 (before implant placement). | 3, 6 and 9 months |
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Inclusion Criteria:
Age: ≥ 18 years.
Exclusion Criteria:
≤ 18 years.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuel Toledano, Professor | Contact | 34 958 243788 | toledano@ugr.es | |
| Raquel Osorio, Professor | Contact | 34 958 243789 | rosorio@ugr.es |
| Name | Affiliation | Role |
|---|---|---|
| Manuel Toledano, Professor | Universidad de Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental School | Recruiting | Granada | E18071 | Spain |
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