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This study compares two bone graft materials used when placing a dental implant right after tooth removal. One graft fully dissolves (GTO®), the other only partly (Apatos®).
The goal is to see which one better preserves bone and improves appearance around the implant.
This multicenter, double-blind randomized controlled trial aims to compare the clinical, radiographic, and aesthetic outcomes of two xenogeneic bone substitutes, GTO® (fully resorbable) and Apatos® (partially resorbable), used in post-extractive sockets at the time of immediate implant placement.
Eligible patients are adults requiring a single-tooth extraction in the maxilla or mandible, followed by immediate implant placement.
The primary outcome is peri-implant bone volume changes over time, assessed using CBCT scans.
Secondary outcomes include implant and crown failure, implant stability, marginal bone level changes on periapical radiographs, and aesthetic outcomes evaluated using the pink esthetic score based on clinical photographs.
Patients will be followed up to 5 years after loading.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resorbable Bone Substitute (GTO®) | Experimental | Patients receive a fully resorbable bone substitute (GTO®) to fill the gap between the implant and the buccal bone wall during immediate post-extraction implant placement. |
|
| Partially Resorbable Bone Substitute (Apatos®) | Active Comparator | Patients receive a partially resorbable bone substitute (Apatos®) to fill the gap between the implant and the buccal bone wall during immediate post-extraction implant placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GTO® (fully resorbable bone substitute) | Biological | Collagenated heterologous cortico-cancellous porcine bone mix + thermogelling copolymer with collagen (GTO®, OsteoBiol®, Tecnoss®) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in peri-implant bone volumes | Volumetric changes in peri-implant tissues will be measured using limited-view CBCT scans taken at implant placement (baseline), 1 year, and 5 years after loading. The main endpoint is the difference in bone volume between baseline and 1 year. | From enrollment to 5 years after implant loading |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with crown or implant failure | Defined as the inability to place the crown due to implant failure, or the need for crown replacement for any reason. Implant failure is defined as implant mobility and/or any infection dictating implant removal and any mechanical complications rendering the implant unusable (e.g. implant fracture). The stability of each individual implant will be measured by the blinded outcome assessor manually by assessing the stability of the crown using the handles of two metallic instruments at 1 and 5 years after loading. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Esposito, Dentistry | Associate Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Juan Carlos University | Madrid | Madrid | 28933 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16307569 | Background | Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x. | |
| 23647007 | Background | Thalmair T, Fickl S, Schneider D, Hinze M, Wachtel H. Dimensional alterations of extraction sites after different alveolar ridge preservation techniques - a volumetric study. J Clin Periodontol. 2013 Jul;40(7):721-7. doi: 10.1111/jcpe.12111. Epub 2013 May 5. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 18, 2018 | Jul 1, 2025 |
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| Apatos® (partially resorbable bone substitute) | Biological | Porcine cortical bone granules (Apatos Cortical®, OsteoBiol®, Tecnoss®) stabilized with TSV Gel®, a thermogelling copolymer with collagen. |
|
| From enrollment to 5 years after implant loading |
| Number of biological and biomechanical complications | Biological and biomechanical complications will be recorded and reported by study group. Examples of biological complications are: fistula, peri-implantitis. Examples of biomechanical complications are fracture of the metal screws, loosening of the crown, fracture of the ceramic lining. | From enrollment to 5 years after implant loading |
| Peri-implant marginal bone level changes | Periapical digital radiographs will be made with the paralleling technique at implant placement, at 1 and 5 years of loading. In case of an unreadable radiograph, the radiograph must be made again. Peri-implant marginal bone levels will be measured using the Image J (National Institutes of Health, Bethesda, Maryland, USA) software. The software will be calibrated for every single image using the known implant length or, if the full implants is not visible on the radiograph, the implant diameter. Measurements of the mesial and distal bone crest level adjacent to each implant will be made to the nearest 0.01 mm. Reference points for the linear measurements will be: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact. Bone levels will be measured at both mesial and distal sides and averaged. Bone level at single implants will be averaged at group level. | From enrollment to 5 years after implant loading |
| Aesthetic evaluation using the Pink Esthetic Score (0-14; higher scores = better outcome) | Aesthetic evaluation of the clinical pictures taken at delivery of the final crown (baseline), at 1- and 5-year follow-ups, on a computer screen by an independent blinded dentist. The pictures of the vestibular and occlusal aspects must include the two adjacent teeth. The aesthetic evaluation will be done following thePink Esthetic Score, a validated index that ranges from 0 (worst aesthetic outcome) to 14 (best aesthetic outcome), based on soft tissue parameters around the implant implant-supported crown. | From enrollment to 5 years after implant loading |
| 22282729 | Background | De Angelis N, Felice P, Pellegrino G, Camurati A, Gambino P, Esposito M. Guided bone regeneration with and without a bone substitute at single post-extractive implants: 1-year post-loading results from a pragmatic multicentre randomised controlled trial. Eur J Oral Implantol. 2011 Winter;4(4):313-25. |
| 20824846 | Background | Esposito M, Grusovin MG, Polyzos IP, Felice P, Worthington HV. Interventions for replacing missing teeth: dental implants in fresh extraction sockets (immediate, immediate-delayed and delayed implants). Cochrane Database Syst Rev. 2010 Sep 8;2010(9):CD005968. doi: 10.1002/14651858.CD005968.pub3. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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