Alveolar Bone ResorptionBIO-OI-TECHEIPNCT07746869
Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using BIOTECK Materials and OITECH Implant System
An observational study of Alveolar Bone Resorption, run by Bioteck S.p.A. at 1 site in Spain.
Trial summary
This randomized controlled clinical study aims to compare two healing periods (4 vs 6 months) after extraction socket preservation using equine-derived enzymatically treated biomaterials (BIOTECK® system), prior to implant placement with the OITECH implant system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Bone Resorption
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential participants will be identified among patients treated at the University of Granada's Clinic for Advanced Comprehensive Dentistry and Implantology and Periodontology and Implants, either during routine diagnostic visits or through internal referrals. Patients who have a tooth-preferably an anterior tooth or premolar-for which extraction is clinically indicated and who express their intention to restore the area through the subsequent placement of a dental implant will be considered potential candidates.
Who may be able to join
- Age: ≥ 18 years.
- Good general health. Need for extraction of incisors, canines, or premolars due to caries, endodontic complications, root fracture, or prosthetic reasons.
- Presence of three intact alveolar walls following tooth extraction, with a defect in the vestibular wall (<50%).
- Need for treatment with single-tooth implants, with adjacent teeth and occlusal antagonists present.
- Sufficient available bone, as assessed by CBCT, for the placement of implants 3.6 mm in diameter and 10 mm in length.
- Periodontal health with intact or reduced periodontium. Full-mouth plaque and bleeding scores < 20%.
- Ability and willingness to follow the study procedures and instructions.
Who cannot join
- Compromised health status. Presence of any systemic condition, such as uncontrolled diabetes mellitus, cancer, HIV, disorders that impair wound healing, chronic high-dose steroid therapy, intravenous and oral bisphosphonate therapy, metabolic bone diseases, a history of head and neck radiation, or any other immunosuppressive therapy that contraindicates oral surgical treatment.
- Absence of adjacent teeth or opposing occlusal teeth.
- The missing tooth is a molar.
- More than one defect in the bone wall or a buccal defect >50%.
- Allergy or hypersensitivity to medications or any product used during the study.
- Regular use of tobacco (defined as >1 cigarette per day) or chewing tobacco, even within the 3 months prior to enrollment.
Show all 9Show fewer
- Untreated periodontitis.
- Acute periapical or periodontal infection.
- Oral plaque and/or bleeding > 20%.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Di Bona contact
Spain1 site
Unidad Clínica del Máster de Odontología Integral Avanzada e Implantología. Departamento de Estomatología. Universidad de Granada
Granada, Granada, 18071
About this study
Official title: Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using BIOTECK Materials and OITECH Implant System: A Randomized Controlled Clinical Study
This randomized controlled clinical study aims to compare two healing periods (4 vs 6 months) after extraction socket preservation using equine-derived enzymatically treated biomaterials (BIOTECK® system), prior to implant placement with the OITECH implant system. The study evaluates whether early implant placement at 4 months provides comparable or non-inferior outcomes to the conventional 6-month protocol in terms of primary implant stability, bone quality, and histological bone regeneration. Secondary outcomes include marginal bone level maintenance, peri-implant tissue health, implant survival, and the incidence of complications during follow-up. The goal is to generate clinical evidence to optimize the timing of implant placement without altering established treatment protocols.
- Conditions
- Alveolar Bone Resorption
- Keywords
- Activabone® Mouldable, HEART®, Xenomatrix®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Guided bone regeneration procedure with Activabone® Mouldable Paste, as bone graft, the pericardium collagen membrane (Heart®) and stabilized with the collagen matrix Xenomatrix® (Bioteck S.p.A., Italy). Implant OITECH will be inserted 4 months after GBR procedure. | |
| Control group | Guided bone regeneration procedure with Activabone® Mouldable Paste, as bone graft, the pericardium collagen membrane (Heart®) and stabilized with the collagen matrix Xenomatrix® (Bioteck S.p.A., Italy). Implant OITECH will be inserted 6 months after GBR procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Stability Quotient (ISQ) by Resonance Frequecy Analysis (RFA)
Implant stability will be assessed using resonance frequency analysis (RFA) with the Osstell IDx device (Osstell, Gothenburg, Sweden), which provides Implant Stability Quotient (ISQ) values. Two measurements will be obtained for each implant, one in the mesiodistal direction and one in the buccolingual/palatal direction. ISQ values range from 1 to 99, with higher values indicating greater implant stability. The same operator will perform all stability measurements.
Measured: At implant placement, at the second surgical phase (three months after implantation), and before prosthetic loading.
CBCT-assessed reduction in alveolar ridge height and width
Each patient will undergo Cone Beam Computed Tomography (CBCT) scans to assess changes in height and width. The cross-sections from T0 and T1 will be superimposed and aligned to determine the following reference lines. The percentage reduction in height and width will be calculated.
Measured: One scan immediately after regenerative surgery (T0) and a second scan after a healing period of 6 or 4 months, prior to implant placement (T1).
Percentage of newly formed bone, residual graft material, and bone marrow/connective tissue
The cylindrical bone sample extracted during implant site preparation will be analyzed. The sample will undergo resin embedding without decalcification and histological preparation for subsequent staining (toluidine blue, Von Kossa, and hematoxylin/eosin).
Histomorphometric analysis will be performed using optical microscopy and image analysis software to quantify the percentage of each tissue component within the biopsy specimen.
Measured: Prior to implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study startSep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone ResorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioteck S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad de Granada
- Responsible party
- Sponsor
- Investigators
- Manuel Toledano, DDS, PhD, Principal investigator, Universidad de Granada, Granada, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746869
- Sponsor's protocol ID
- 2025_TIEMPOS_IMP
- Acronym
- BIO-OI-TECHEIP
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Urban IA, Monje A. Guided Bone Regeneration in Alveolar Bone Reconstruction. Oral Maxillofac Surg Clin North Am. 2019 May;31(2):331-338. doi: 10.1016/j.coms.2019.01.003.
PubMed 30947850Toledano M, Vallecillo C, Gutierrez-Corrales A, Torres-Lagares D, Toledano-Osorio M, Serrera-Figallo MA. Histomorphometric Analysis of Differential Regional Bone Regeneration Induced by Distinct Doped Membranes. Polymers (Basel). 2022 May 19;14(10):2078. doi: 10.3390/polym14102078.
PubMed 35631960Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x.
PubMed 22211303Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
PubMed 12956475Sanz M, Cecchinato D, Ferrus J, Pjetursson EB, Lang NP, Lindhe J. A prospective, randomized-controlled clinical trial to evaluate bone preservation using implants with different geometry placed into extraction sockets in the maxilla. Clin Oral Implants Res. 2010 Jan;21(1):13-21. doi: 10.1111/j.1600-0501.2009.01824.x. Epub 2009 Nov 18.
PubMed 19922492Monje A, Ravida A, Wang HL, Helms JA, Brunski JB. Relationship Between Primary/Mechanical and Secondary/Biological Implant Stability. Int J Oral Maxillofac Implants. 2019 Suppl;34:s7-s23. doi: 10.11607/jomi.19suppl.g1.
PubMed 31116830Mardas N, Trullenque-Eriksson A, MacBeth N, Petrie A, Donos N. Does ridge preservation following tooth extraction improve implant treatment outcomes: a systematic review: Group 4: Therapeutic concepts & methods. Clin Oral Implants Res. 2015 Sep;26 Suppl 11:180-201. doi: 10.1111/clr.12639. Epub 2015 Jun 16.
PubMed 26078004Lages FS, Douglas-de Oliveira DW, Costa FO. Relationship between implant stability measurements obtained by insertion torque and resonance frequency analysis: A systematic review. Clin Implant Dent Relat Res. 2018 Feb;20(1):26-33. doi: 10.1111/cid.12565. Epub 2017 Dec 1.
PubMed 29194944Heberer S, Al-Chawaf B, Hildebrand D, Nelson JJ, Nelson K. Histomorphometric analysis of extraction sockets augmented with Bio-Oss Collagen after a 6-week healing period: a prospective study. Clin Oral Implants Res. 2008 Dec;19(12):1219-25. doi: 10.1111/j.1600-0501.2008.01617.x. No abstract available.
PubMed 19040436Gallucci GO, Benic GI, Eckert SE, Papaspyridakos P, Schimmel M, Schrott A, Weber HP. Consensus statements and clinical recommendations for implant loading protocols. Int J Oral Maxillofac Implants. 2014;29 Suppl:287-90. doi: 10.11607/jomi.2013.g4. No abstract available.
PubMed 24660204Di Stefano DA, Artese L, Iezzi G, Piattelli A, Pagnutti S, Piccirilli M, Perrotti V. Alveolar ridge regeneration with equine spongy bone: a clinical, histological, and immunohistochemical case series. Clin Implant Dent Relat Res. 2009 Jun;11(2):90-100. doi: 10.1111/j.1708-8208.2008.00104.x. Epub 2008 Sep 9.
PubMed 18783426Couso-Queiruga E, Stuhr S, Tattan M, Chambrone L, Avila-Ortiz G. Post-extraction dimensional changes: A systematic review and meta-analysis. J Clin Periodontol. 2021 Jan;48(1):126-144. doi: 10.1111/jcpe.13390. Epub 2020 Nov 4.
PubMed 33067890Buser D, Chappuis V, Belser UC, Chen S. Implant placement post extraction in esthetic single tooth sites: when immediate, when early, when late? Periodontol 2000. 2017 Feb;73(1):84-102. doi: 10.1111/prd.12170.
PubMed 28000278Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057.
PubMed 30623987
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using BIOTECK Materials and OITECH Implant System: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07746869
- Acronym / sponsor ID
- BIO-OI-TECHEIP / 2025_TIEMPOS_IMP
- Conditions
- Alveolar Bone Resorption
- Keywords
- Activabone® Mouldable, HEART®, Xenomatrix®
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bioteck S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- Universidad de Granada
- Study start
- Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled clinical study aims to compare two healing periods (4 vs 6 months) after extraction socket preservation using equine-derived enzymatically treated biomaterials (BIOTECK® system), prior to implant placement with the OITECH implant system. The study evaluates whether early implant placement at 4 months provides comparable or non-inferior outcomes to the conventional 6-month protocol in terms of primary implant stability, bone quality, and histological bone regeneration. Secondary outcomes include marginal bone level maintenance, peri-implant tissue health, implant survival, and the incidence of complications during follow-up. The goal is to generate clinical evidence to optimize the timing of implant placement without altering established treatment protocols.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | – | –Guided bone regeneration procedure with Activabone® Mouldable Paste, as bone graft, the pericardium collagen membrane (Heart®) and stabilized with the collagen matrix Xenomatrix® (Bioteck S.p.A., Italy). Implant OITECH will be inserted 4 months after GBR procedure. |
| Control group | – | –Guided bone regeneration procedure with Activabone® Mouldable Paste, as bone graft, the pericardium collagen membrane (Heart®) and stabilized with the collagen matrix Xenomatrix® (Bioteck S.p.A., Italy). Implant OITECH will be inserted 6 months after GBR procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential participants will be identified among patients treated at the University of Granada's Clinic for Advanced Comprehensive Dentistry and Implantology and Periodontology and Implants, either during routine diagnostic visits or through internal referrals. Patients who have a tooth-preferably an anterior tooth or premolar-for which extraction is clinically indicated and who express their intention to restore the area through the subsequent placement of a dental implant will be considered potential candidates.
Key inclusion criteria (7 listed)
- Age: ≥ 18 years.
- Good general health. Need for extraction of incisors, canines, or premolars due to caries, endodontic complications, root fracture, or prosthetic reasons.
- Presence of three intact alveolar walls following tooth extraction, with a defect in the vestibular wall (<50%).
- Need for treatment with single-tooth implants, with adjacent teeth and occlusal antagonists present.
- Sufficient available bone, as assessed by CBCT, for the placement of implants 3.6 mm in diameter and 10 mm in length.
Key exclusion criteria (9 listed)
- Compromised health status. Presence of any systemic condition, such as uncontrolled diabetes mellitus, cancer, HIV, disorders that impair wound healing, chronic high-dose steroid therapy, intravenous and oral bisphosphonate therapy, metabolic bone diseases, a history of head and neck radiation, or any other immunosuppressive therapy that contraindicates oral surgical treatment.
- Absence of adjacent teeth or opposing occlusal teeth.
- The missing tooth is a molar.
- More than one defect in the bone wall or a buccal defect >50%.
- Allergy or hypersensitivity to medications or any product used during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Implant Stability Quotient (ISQ) by Resonance Frequecy Analysis (RFA)
Time frame: At implant placement, at the second surgical phase (three months after implantation), and before prosthetic loading.
Implant stability will be assessed using resonance frequency analysis (RFA) with the Osstell IDx device (Osstell, Gothenburg, Sweden), which provides Implant Stability Quotient (ISQ) values. Two measurements will be obtained for each implant, one in the mesiodistal direction and one in the buccolingual/palatal direction. ISQ values range from 1 to 99, with higher values indicating greater implant stability. The same operator will perform all stability measurements.
CBCT-assessed reduction in alveolar ridge height and width
Time frame: One scan immediately after regenerative surgery (T0) and a second scan after a healing period of 6 or 4 months, prior to implant placement (T1).
Each patient will undergo Cone Beam Computed Tomography (CBCT) scans to assess changes in height and width. The cross-sections from T0 and T1 will be superimposed and aligned to determine the following reference lines. The percentage reduction in height and width will be calculated.
Percentage of newly formed bone, residual graft material, and bone marrow/connective tissue
Time frame: Prior to implant placement
The cylindrical bone sample extracted during implant site preparation will be analyzed. The sample will undergo resin embedding without decalcification and histological preparation for subsequent staining (toluidine blue, Von Kossa, and hematoxylin/eosin). Histomorphometric analysis will be performed using optical microscopy and image analysis software to quantify the percentage of each tissue component within the biopsy specimen.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Background: PubMed 30947850Urban IA, Monje A. Guided Bone Regeneration in Alveolar Bone Reconstruction. Oral Maxillofac Surg Clin North Am. 2019 May;31(2):331-338. doi: 10.1016/j.coms.2019.01.003.
- Background: PubMed 35631960Toledano M, Vallecillo C, Gutierrez-Corrales A, Torres-Lagares D, Toledano-Osorio M, Serrera-Figallo MA. Histomorphometric Analysis of Differential Regional Bone Regeneration Induced by Distinct Doped Membranes. Polymers (Basel). 2022 May 19;14(10):2078. doi: 10.3390/polym14102078.
- Background: PubMed 22211303Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x.
- Background: PubMed 12956475Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
- Background: PubMed 19922492Sanz M, Cecchinato D, Ferrus J, Pjetursson EB, Lang NP, Lindhe J. A prospective, randomized-controlled clinical trial to evaluate bone preservation using implants with different geometry placed into extraction sockets in the maxilla. Clin Oral Implants Res. 2010 Jan;21(1):13-21. doi: 10.1111/j.1600-0501.2009.01824.x. Epub 2009 Nov 18.
- Background: PubMed 31116830Monje A, Ravida A, Wang HL, Helms JA, Brunski JB. Relationship Between Primary/Mechanical and Secondary/Biological Implant Stability. Int J Oral Maxillofac Implants. 2019 Suppl;34:s7-s23. doi: 10.11607/jomi.19suppl.g1.
- Background: PubMed 26078004Mardas N, Trullenque-Eriksson A, MacBeth N, Petrie A, Donos N. Does ridge preservation following tooth extraction improve implant treatment outcomes: a systematic review: Group 4: Therapeutic concepts & methods. Clin Oral Implants Res. 2015 Sep;26 Suppl 11:180-201. doi: 10.1111/clr.12639. Epub 2015 Jun 16.
- Background: PubMed 29194944Lages FS, Douglas-de Oliveira DW, Costa FO. Relationship between implant stability measurements obtained by insertion torque and resonance frequency analysis: A systematic review. Clin Implant Dent Relat Res. 2018 Feb;20(1):26-33. doi: 10.1111/cid.12565. Epub 2017 Dec 1.
- Background: PubMed 19040436Heberer S, Al-Chawaf B, Hildebrand D, Nelson JJ, Nelson K. Histomorphometric analysis of extraction sockets augmented with Bio-Oss Collagen after a 6-week healing period: a prospective study. Clin Oral Implants Res. 2008 Dec;19(12):1219-25. doi: 10.1111/j.1600-0501.2008.01617.x. No abstract available.
- Background: PubMed 24660204Gallucci GO, Benic GI, Eckert SE, Papaspyridakos P, Schimmel M, Schrott A, Weber HP. Consensus statements and clinical recommendations for implant loading protocols. Int J Oral Maxillofac Implants. 2014;29 Suppl:287-90. doi: 10.11607/jomi.2013.g4. No abstract available.
- Background: PubMed 18783426Di Stefano DA, Artese L, Iezzi G, Piattelli A, Pagnutti S, Piccirilli M, Perrotti V. Alveolar ridge regeneration with equine spongy bone: a clinical, histological, and immunohistochemical case series. Clin Implant Dent Relat Res. 2009 Jun;11(2):90-100. doi: 10.1111/j.1708-8208.2008.00104.x. Epub 2008 Sep 9.
- Background: PubMed 33067890Couso-Queiruga E, Stuhr S, Tattan M, Chambrone L, Avila-Ortiz G. Post-extraction dimensional changes: A systematic review and meta-analysis. J Clin Periodontol. 2021 Jan;48(1):126-144. doi: 10.1111/jcpe.13390. Epub 2020 Nov 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Di Bona contact
Manuel Toledano, DDS, PhD principal investigator
Universidad de Granada, Granada, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alveolar Bone Resorption, run by Bioteck S.p.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Morroni (0444 289366 ext. +39, m.morroni@bioteck.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Stability Quotient (ISQ) by Resonance Frequecy Analysis (RFA) (time frame: At implant placement, at the second surgical phase (three months after implantation), and before prosthetic loading.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07746869, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.