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Tooth Roots for Lateral Alveolar Ridge Augmentation

Primary Purpose

Bone Atrophy, Alveolar

Status
Unknown status
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
tooth root augmentation
Sponsored by
St. Catherine Specialty Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Atrophy, Alveolar focused on measuring bone augmentation, autogenous tooth roots, dental implants

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St. Catherine Specialty Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bone defect surgery

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
gain in ridge width (CWg)
CWg (mm) = CWb ( ridge after surgery in mm)- CWa ( ridge before surgery in mm)
soft tissue dehiscences
yes/no for secondary wound healing
wound infections
monitoring whether there is an increased incidence of inflammatory conditions after the specified procedure

Full Information

First Posted
December 8, 2020
Last Updated
December 16, 2020
Sponsor
St. Catherine Specialty Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04678674
Brief Title
Tooth Roots for Lateral Alveolar Ridge Augmentation
Official Title
Autogenous Tooth Roots for Lateral Alveolar Ridge Augmentation and Staged Implant Placement
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Catherine Specialty Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Atrophy, Alveolar
Keywords
bone augmentation, autogenous tooth roots, dental implants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bone defect surgery
Arm Type
Experimental
Arm Description
augmentation on insufficient alveolar ridges with autologous teeth will be performed (wisdom tooth or periodontally compromised tooth)
Intervention Type
Procedure
Intervention Name(s)
tooth root augmentation
Intervention Description
Autogenous tooth roots for lateral alveolar ridge augmentation and staged implant placement.
Primary Outcome Measure Information:
Title
The primary endpoint was defined as the clinical width (CW) of the alveolar ridge
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Periimplant tissue stability of augmented sites after prosthetic rehabilitation
Description
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.
Time Frame
12 months
Title
gain in ridge width (CWg)
Description
CWg (mm) = CWb ( ridge after surgery in mm)- CWa ( ridge before surgery in mm)
Time Frame
6 months
Title
soft tissue dehiscences
Description
yes/no for secondary wound healing
Time Frame
6 months
Title
wound infections
Description
monitoring whether there is an increased incidence of inflammatory conditions after the specified procedure
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dragana Gabrić, PhD
Organizational Affiliation
School of Dental Medicine Zagreb
Official's Role
Study Director
Facility Information:
Facility Name
St. Catherine Specialty Hospital
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
individual participant data will be available all time
IPD Sharing Time Frame
12 moths
IPD Sharing Access Criteria
only researchers
Citations:
PubMed Identifier
25615925
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.
Results Reference
background
PubMed Identifier
17298495
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. doi: 10.1111/j.1600-0501.2006.01301.x. Epub 2007 Feb 13.
Results Reference
background
PubMed Identifier
30624791
Citation
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.
Results Reference
background
PubMed Identifier
20476887
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.
Results Reference
result
PubMed Identifier
24597718
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):380-384. doi: 10.1111/edt.12101. Epub 2014 Mar 5.
Results Reference
result
PubMed Identifier
27028526
Citation
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.
Results Reference
result
PubMed Identifier
26580310
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.
Results Reference
result
PubMed Identifier
27169909
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.
Results Reference
result
PubMed Identifier
30413950
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. Epub 2018 Nov 9.
Results Reference
result
PubMed Identifier
30791121
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 Mar 28.
Results Reference
result

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Tooth Roots for Lateral Alveolar Ridge Augmentation

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