Bone Atrophy, AlveolarNCT04678674
Tooth Roots for Lateral Alveolar Ridge Augmentation
A study testing tooth root augmentation in people with Bone Atrophy, Alveolar, run by St. Catherine Specialty Hospital at 1 site in Croatia.
Trial summary
A deficient alveolar ridge segment in prepara¬tion for implant placement can be regenerated by several techniques. The type of graft material for each patient depends on many factors such as the anatomy, the morphology of the bone defect, type of prosthodontic rehabilitation and patient or clinician preferences. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Atrophy, Alveolar
- What is being tested?
- tooth root augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCroatia
- Study dates
- 15 Jan 2019to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18 to 60 years
- candidate for lateral ridge augmentation
- insufficient bone ridge width at the recipient site for implant placement
- sufficient bone height at the recipient site for implant placement and (e)
- healthy oral mucosa
- at least 2 mm keratinized tissue
Who cannot join
- general contraindications for dental and/or surgical treatments
- inflammatory and autoimmune disease of the oral cavity,
- uncontrolled diabetes (HbA1c > 7%)
- history of chemotherapy or radiotherapy within the past five years,
- previous immunosuppressant, bisphosphonate or high- dose corticosteroid therapy
- smokers
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autogenous Tooth Roots for Lateral Alveolar Ridge Augmentation and Staged Implant Placement
A deficient alveolar ridge segment in prepara¬tion for implant placement can be regenerated by several techniques. The type of graft material for each patient depends on many factors such as the anatomy, the morphology of the bone defect, type of prosthodontic rehabilitation and patient or clinician preferences. Bone graft material should have three properties that made it ideal: a) osteoconduction, it provides scaffolds for bone regeneration; b) osteoinduction, it promotes the recruitment of bone-forming cells and formation of bone and c) osteogenesis, induction of cells in the graft to promote regeneration of the bone.
Despite of the development of different types of graft material, autogenous bone is still the gold standard for bone augmentation because it exhibits these three mentioned properties. Although it has many advantages, autologous bone has some disadvantages such as high resorption rate up to 50 %, limited source and donor site morbidity. Allografts, xenografts and alloplastic bone graft are materials that are used in everyday practice and over long period, but their disadvantages are numerous in comparison with autologous bone. Allografts can be carrier of some disease and show lack of osteoproliferation, while alloplasts and xenografts show only osteoconduction. According to these facts, it is obvious that there is a need for development an alternative graft material that will surpass these disadvantages.The reconstruction of deficient alveolar ridge defect by the lateral bone augmentation prior to the dental implant placement is predictable and commonly used method. Except animal studies, recent clinical studies showed that there is no difference in the osseointegration of titanium implants in deficient alveolar ridges reconstructed with autogenous cortical bone blocks or autogenous teeth.
- Conditions
- Bone Atrophy, Alveolar
- Being tested
- tooth root augmentation
- Keywords
- bone augmentation, autogenous tooth roots, dental implants
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tooth root augmentationProcedure or surgery
Autogenous tooth roots for lateral alveolar ridge augmentation and staged implant placement.
| Study group | Role | What they receive |
|---|---|---|
| bone defect surgery | Experimental | augmentation on insufficient alveolar ridges with autologous teeth will be performed (wisdom tooth or periodontally compromised tooth) Receives: Procedure: tooth root augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint was defined as the clinical width (CW) of the alveolar ridge
The primary endpoint was defined as the clinical width (CW) of the alveolar ridge being sufficient for the placement of an adequately dimensioned dental implant without the need for a secondary grafting at 6 months after surgery in either group. CW was assessed before (CWa) and after (CWb) augmentation healing period of 6 months in cone-beam computed tomography (CBCT) scans.
Measurements were performed to the nearest 0.5mm below the crest using a CBCT.
Measured: 6 months
Secondary outcomes (4)
Periimplant tissue stability of augmented sites after prosthetic rehabilitation
Usage of periimplant tissue parameters for assessing the conditions around implants placed in augmented sites using pink esthetic score (PES) that evaluates the esthetic outcome of soft tissue around implant-supported single crowns by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency.
Measured: 12 months
gain in ridge width (CWg)
CWg (mm) = CWb ( ridge after surgery in mm)- CWa ( ridge before surgery in mm)
Measured: 6 months
soft tissue dehiscences
yes/no for secondary wound healing
Measured: 6 months
wound infections
monitoring whether there is an increased incidence of inflammatory conditions after the specified procedure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start15 Jan 2019
- Primary completion1 Sep 2020
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Bone Atrophy, AlveolarStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Catherine Specialty Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Smojver, St. Catherine Specialty Hospital
- Investigators
- Dragana Gabrić, PhD, Study director, School of Dental Medicine Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678674
- Sponsor's protocol ID
- 16041985
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual participant data will be available all time
Publications
Misch CM, Jensen OT, Pikos MA, Malmquist JP. Vertical bone augmentation using recombinant bone morphogenetic protein, mineralized bone allograft, and titanium mesh: a retrospective cone beam computed tomography study. Int J Oral Maxillofac Implants. 2015 Jan-Feb;30(1):202-7. doi: 10.11607/jomi.3977.
PubMed 25615925Roccuzzo M, Ramieri G, Bunino M, Berrone S. Autogenous bone graft alone or associated with titanium mesh for vertical alveolar ridge augmentation: a controlled clinical trial. Clin Oral Implants Res. 2007 Jun;18(3):286-94. doi: 10.1111/j.1600-0501.2006.01301.x. Epub 2007 Feb 13.
PubMed 17298495Naenni N, Lim HC, Papageorgiou SN, Hammerle CHF. Efficacy of lateral bone augmentation prior to implant placement: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:287-306. doi: 10.1111/jcpe.13052.
PubMed 30624791Nampo T, Watahiki J, Enomoto A, Taguchi T, Ono M, Nakano H, Yamamoto G, Irie T, Tachikawa T, Maki K. A new method for alveolar bone repair using extracted teeth for the graft material. J Periodontol. 2010 Sep;81(9):1264-72. doi: 10.1902/jop.2010.100016.
PubMed 20476887Qin X, Raj RM, Liao XF, Shi W, Ma B, Gong SQ, Chen WM, Zhou B. Using rigidly fixed autogenous tooth graft to repair bone defect: an animal model. Dent Traumatol. 2014 Oct;30(5):380-384. doi: 10.1111/edt.12101. Epub 2014 Mar 5.
PubMed 24597718Becker K, Drescher D, Honscheid R, Golubovic V, Mihatovic I, Schwarz F. Biomechanical, micro-computed tomographic and immunohistochemical analysis of early osseous integration at titanium implants placed following lateral ridge augmentation using extracted tooth roots. Clin Oral Implants Res. 2017 Mar;28(3):334-340. doi: 10.1111/clr.12803. Epub 2016 Mar 29.
PubMed 27028526Schwarz F, Golubovic V, Becker K, Mihatovic I. Extracted tooth roots used for lateral alveolar ridge augmentation: a proof-of-concept study. J Clin Periodontol. 2016 Apr;43(4):345-53. doi: 10.1111/jcpe.12481. Epub 2016 Mar 17.
PubMed 26580310Schwarz F, Golubovic V, Mihatovic I, Becker J. Periodontally diseased tooth roots used for lateral alveolar ridge augmentation. A proof-of-concept study. J Clin Periodontol. 2016 Sep;43(9):797-803. doi: 10.1111/jcpe.12579. Epub 2016 Jun 25.
PubMed 27169909Becker K, Jandik K, Stauber M, Mihatovic I, Drescher D, Schwarz F. Microstructural volumetric analysis of lateral ridge augmentation using differently conditioned tooth roots. Clin Oral Investig. 2019 Jul;23(7):3063-3071. doi: 10.1007/s00784-018-2723-4. Epub 2018 Nov 9.
PubMed 30413950Schwarz F, Mihatovic I, Popal-Jensen I, Parvini P, Sader R. Influence of autoclavation on the efficacy of extracted tooth roots used for vertical alveolar ridge augmentation. J Clin Periodontol. 2019 Apr;46(4):502-509. doi: 10.1111/jcpe.13090. Epub 2019 Mar 28.
PubMed 30791121
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autogenous Tooth Roots for Lateral Alveolar Ridge Augmentation and Staged Implant Placement
- ClinicalTrials.gov ID
- NCT04678674
- Acronym / sponsor ID
- 16041985
- Conditions
- Bone Atrophy, Alveolar
- Keywords
- bone augmentation, autogenous tooth roots, dental implants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- St. Catherine Specialty HospitalUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 22 Dec 2020 (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.
A deficient alveolar ridge segment in prepara¬tion for implant placement can be regenerated by several techniques. The type of graft material for each patient depends on many factors such as the anatomy, the morphology of the bone defect, type of prosthodontic rehabilitation and patient or clinician preferences. Bone graft material should have three properties that made it ideal: a) osteoconduction, it provides scaffolds for bone regeneration; b) osteoinduction, it promotes the recruitment of bone-forming cells and formation of bone and c) osteogenesis, induction of cells in the graft to promote regeneration of the bone.
Despite of the development of different types of graft material, autogenous bone is still the gold standard for bone augmentation because it exhibits these three mentioned properties. Although it has many advantages, autologous bone has some disadvantages such as high resorption rate up to 50 %, limited source and donor site morbidity. Allografts, xenografts and alloplastic bone graft are materials that are used in everyday practice and over long period, but their disadvantages are numerous in comparison with autologous bone. Allografts can be carrier of some disease and show lack of osteoproliferation, while alloplasts and xenografts show only osteoconduction. According to these facts, it is obvious that there is a need for development an alternative graft material that will surpass these disadvantages.The reconstruction of deficient alveolar ridge defect by the lateral bone augmentation prior to the dental implant placement is predictable and commonly used method. Except animal studies, recent clinical studies showed that there is no difference in the osseointegration of titanium implants in deficient alveolar ridges reconstructed with autogenous cortical bone blocks or autogenous teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bone defect surgery | Experimental | Procedure: tooth root augmentationaugmentation on insufficient alveolar ridges with autologous teeth will be performed (wisdom tooth or periodontally compromised tooth) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- age 18 to 60 years
- candidate for lateral ridge augmentation
- insufficient bone ridge width at the recipient site for implant placement
- sufficient bone height at the recipient site for implant placement and (e)
- healthy oral mucosa
Key exclusion criteria (7 listed)
- general contraindications for dental and/or surgical treatments
- inflammatory and autoimmune disease of the oral cavity,
- uncontrolled diabetes (HbA1c > 7%)
- history of chemotherapy or radiotherapy within the past five years,
- previous immunosuppressant, bisphosphonate or high- dose corticosteroid therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tooth root augmentationAutogenous tooth roots for lateral alveolar ridge augmentation and staged implant placement. | Procedure or surgery | bone defect surgery |
Primary outcome
The primary endpoint was defined as the clinical width (CW) of the alveolar ridge
Time frame: 6 months
The primary endpoint was defined as the clinical width (CW) of the alveolar ridge being sufficient for the placement of an adequately dimensioned dental implant without the need for a secondary grafting at 6 months after surgery in either group. CW was assessed before (CWa) and after (CWb) augmentation healing period of 6 months in cone-beam computed tomography (CBCT) scans. Measurements were performed to the nearest 0.5mm below the crest using a CBCT.
4 secondary outcomes
Periimplant tissue stability of augmented sites after prosthetic rehabilitation
Time frame: 12 months
gain in ridge width (CWg)
Time frame: 6 months
soft tissue dehiscences
Time frame: 6 months
wound infections
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Background: PubMed 25615925Misch CM, Jensen OT, Pikos MA, Malmquist JP. Vertical bone augmentation using recombinant bone morphogenetic protein, mineralized bone allograft, and titanium mesh: a retrospective cone beam computed tomography study. Int J Oral Maxillofac Implants. 2015 Jan-Feb;30(1):202-7. doi: 10.11607/jomi.3977.
- Background: PubMed 17298495Roccuzzo M, Ramieri G, Bunino M, Berrone S. Autogenous bone graft alone or associated with titanium mesh for vertical alveolar ridge augmentation: a controlled clinical trial. Clin Oral Implants Res. 2007 Jun;18(3):286-94. doi: 10.1111/j.1600-0501.2006.01301.x. Epub 2007 Feb 13.
- Background: PubMed 30624791Naenni N, Lim HC, Papageorgiou SN, Hammerle CHF. Efficacy of lateral bone augmentation prior to implant placement: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:287-306. doi: 10.1111/jcpe.13052.
- Results publication: PubMed 20476887Nampo T, Watahiki J, Enomoto A, Taguchi T, Ono M, Nakano H, Yamamoto G, Irie T, Tachikawa T, Maki K. A new method for alveolar bone repair using extracted teeth for the graft material. J Periodontol. 2010 Sep;81(9):1264-72. doi: 10.1902/jop.2010.100016.
- Results publication: PubMed 24597718Qin X, Raj RM, Liao XF, Shi W, Ma B, Gong SQ, Chen WM, Zhou B. Using rigidly fixed autogenous tooth graft to repair bone defect: an animal model. Dent Traumatol. 2014 Oct;30(5):380-384. doi: 10.1111/edt.12101. Epub 2014 Mar 5.
- Results publication: PubMed 27028526Becker K, Drescher D, Honscheid R, Golubovic V, Mihatovic I, Schwarz F. Biomechanical, micro-computed tomographic and immunohistochemical analysis of early osseous integration at titanium implants placed following lateral ridge augmentation using extracted tooth roots. Clin Oral Implants Res. 2017 Mar;28(3):334-340. doi: 10.1111/clr.12803. Epub 2016 Mar 29.
- Results publication: PubMed 26580310Schwarz F, Golubovic V, Becker K, Mihatovic I. Extracted tooth roots used for lateral alveolar ridge augmentation: a proof-of-concept study. J Clin Periodontol. 2016 Apr;43(4):345-53. doi: 10.1111/jcpe.12481. Epub 2016 Mar 17.
- Results publication: PubMed 27169909Schwarz F, Golubovic V, Mihatovic I, Becker J. Periodontally diseased tooth roots used for lateral alveolar ridge augmentation. A proof-of-concept study. J Clin Periodontol. 2016 Sep;43(9):797-803. doi: 10.1111/jcpe.12579. Epub 2016 Jun 25.
- Results publication: PubMed 30413950Becker K, Jandik K, Stauber M, Mihatovic I, Drescher D, Schwarz F. Microstructural volumetric analysis of lateral ridge augmentation using differently conditioned tooth roots. Clin Oral Investig. 2019 Jul;23(7):3063-3071. doi: 10.1007/s00784-018-2723-4. Epub 2018 Nov 9.
- Results publication: PubMed 30791121Schwarz F, Mihatovic I, Popal-Jensen I, Parvini P, Sader R. Influence of autoclavation on the efficacy of extracted tooth roots used for vertical alveolar ridge augmentation. J Clin Periodontol. 2019 Apr;46(4):502-509. doi: 10.1111/jcpe.13090. Epub 2019 Mar 28.
- Individual participant dataSharing planned: Yes. individual participant data will be available all time
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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. This study is not recruiting at the moment.
Dragana Gabrić, PhD study director
School of Dental Medicine Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tooth root augmentation in people with Bone Atrophy, Alveolar, run by St. Catherine Specialty Hospital at 1 site in Croatia.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 Dec 2020. 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 Croatia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint was defined as the clinical width (CW) of the alveolar ridge (time frame: 6 months). 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 NCT04678674, which also lists 10 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 22 Dec 2020.