Tooth Roots for Lateral Alveolar Ridge Augmentation

Bone Atrophy, Alveolar Clinical Trial

Official title:

Autogenous Tooth Roots for Lateral Alveolar Ridge Augmentation and Staged Implant Placement

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04678674
• Other study ID #: 16041985
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2020
• Source: St. Catherine Specialty Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Atrophy
• Bone Atrophy, Alveolar

Intervention

Procedure:
• tooth root augmentation
Autogenous tooth roots for lateral alveolar ridge augmentation and staged implant placement.

Locations

Country	Name	City	State
Croatia	St. Catherine Specialty Hospital	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
St. Catherine Specialty Hospital

Country where clinical trial is conducted

Croatia, 

References & Publications (10)

Becker K, Drescher D, Hönscheid 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 extracte — View Citation

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. E — View Citation

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. — View Citation

Naenni N, Lim HC, Papageorgiou SN, Hämmerle 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. — View Citation

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. — View Citation

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):380-4. doi: 10.1111/edt.12101. Epub 2014 Mar 5. — View Citation

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. Epub 2007 Feb 13. — View Citation

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. — View Citation

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. — View Citation

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 M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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.	12 months
Secondary	gain in ridge width (CWg)	CWg (mm) = CWb ( ridge after surgery in mm)- CWa ( ridge before surgery in mm)	6 months
Secondary	soft tissue dehiscences	yes/no for secondary wound healing	6 months
Secondary	wound infections	monitoring whether there is an increased incidence of inflammatory conditions after the specified procedure	6 months