Tooth Roots for Lateral Alveolar Ridge Augmentation

NCT04678674 | Unknown DMC

• 1 other identifier: 16041985
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bone Atrophy, Alveolar

Keywords

bone augmentation; autogenous tooth roots; dental implants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Periimplant tissue stability of augmented sites after prosthetic rehabilitation

  12 months

• gain in ridge width (CWg)

  6 months

• soft tissue dehiscences

  6 months

• wound infections

  6 months

Study Arms (1)

bone defect surgery

EXPERIMENTAL

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

Procedure: tooth root augmentation

Interventions

tooth root augmentation PROCEDURE

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

bone defect surgery

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Catherine Specialty Hospital: lead

Study Sites (1)

St. Catherine Specialty Hospital

Zagreb, 10000, Croatia

Location

Related Publications (10)

• 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.

  PMID: 25615925 BACKGROUND

• 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.

  PMID: 17298495 BACKGROUND

• 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.

  PMID: 30624791 BACKGROUND

• 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.

  PMID: 20476887 RESULT

• 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.

  PMID: 24597718 RESULT

• 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.

  PMID: 27028526 RESULT

• 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.

  PMID: 26580310 RESULT

• 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.

  PMID: 27169909 RESULT

• 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.

  PMID: 30413950 RESULT

• 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.

  PMID: 30791121 RESULT

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Dragana Gabrić, PhD

  School of Dental Medicine Zagreb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 22, 2020
• Study Start: January 15, 2019
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2021
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 12 moths
• Access Criteria: only researchers

Locations

CR (1)