Tooth Roots for Lateral Alveolar Ridge Augmentation

NCT ID: NCT04678674

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2021-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Atrophy, Alveolar

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

bone augmentation autogenous tooth roots dental implants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

bone defect surgery

augmentation on insufficient alveolar ridges with autologous teeth will be performed (wisdom tooth or periodontally compromised tooth)

Group Type EXPERIMENTAL

tooth root augmentation

Intervention Type PROCEDURE

Autogenous tooth roots for lateral alveolar ridge augmentation and staged implant placement.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tooth root augmentation

Autogenous tooth roots for lateral alveolar ridge augmentation and staged implant placement.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Catherine Specialty Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Igor Smojver

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dragana Gabrić, PhD

Role: STUDY_DIRECTOR

School of Dental Medicine Zagreb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St. Catherine Specialty Hospital

Zagreb, , Croatia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Croatia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25615925 (View on PubMed)

Roccuzzo 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.

Reference Type BACKGROUND
PMID: 17298495 (View on PubMed)

Naenni 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.

Reference Type BACKGROUND
PMID: 30624791 (View on PubMed)

Nampo 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.

Reference Type RESULT
PMID: 20476887 (View on PubMed)

Qin 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.

Reference Type RESULT
PMID: 24597718 (View on PubMed)

Becker 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.

Reference Type RESULT
PMID: 27028526 (View on PubMed)

Schwarz 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.

Reference Type RESULT
PMID: 26580310 (View on PubMed)

Schwarz 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.

Reference Type RESULT
PMID: 27169909 (View on PubMed)

Becker 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.

Reference Type RESULT
PMID: 30413950 (View on PubMed)

Schwarz 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.

Reference Type RESULT
PMID: 30791121 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

16041985

Identifier Type: -

Identifier Source: org_study_id