Trial document




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  DRKS00009586

Trial Description

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Title

Extracted tooth roots (rootgrafts) as autogenous transplants for localized alveolar ridge augmentation. A controlled clinical study.

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Trial Acronym

rootgrafts

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Recent experimental data have indicated, that extracted teeth/ tooth roots may reveal a structural and biological potential to serve as alternative autografts for localized ridge augmentation, thus enabling the insertion of dental implants to restore the masticatory function.
This controlled clinical study aims at investigating the efficacy of this new method in humans. It is hypothesized that extracted teeth/ roots are as effective as the current standard of care (i.e. autogenous bone).

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Brief Summary in Scientific Language

This controlled clinical study aims at clinically, immunologically and microbiologically evaluating the efficacy of differently conditioned (i.e. healthy and endodontically treated) extracted fully developed tooth roots serving as autografts for lateral ridge augmentation and two-stage osseointegration of titanium implants in humans. Cortical autogenous bone blocks harvested from the retromolar area will serve as control treatments.

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Organizational Data

  •   DRKS00009586
  •   2016/02/10
  •   [---]*
  •   yes
  •   Approved
  •   4837R, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

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Health Condition or Problem studied

  •   localized alveolar ridge defects
  •   K08.1 -  Loss of teeth due to accident, extraction or local periodontal disease
  •   K08.2 -  Atrophy of edentulous alveolar ridge
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Interventions/Observational Groups

  •   Autogenous tooth roots (retained, impacted teeth) used as autotransplants for localized alveolar ridge augmentation
  •   Autogenous tooth roots (endodontically treated teeth) used as autotransplants for localized alveolar ridge augmentation
  •   Autogenous (retromolar) bone blocks used as autotransplants for localized alveolar ridge augmentation
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Clinical width of the alveolar ridge at 26 weeks (calibrated caliper)

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Secondary Outcome

-Soft tissue healing at day 10, week 4, 13, 26, 26 +10 days, 26 + 10 weeks and 26 + 26 weeks (arbitrary scale)
-Implant Survival (yes/ no)
-Peri-implant indices (i.e. plaque index - PI, bleeding on probing - BOP, probing pocket depth – PD, mucosal recession - MR) at 26 + 10 weeks and 26 + 26 weeks
-Immunological analysis of matrixmetalloproteinase- 8 at 26 + 10 weeks and 26 + 26 weeks
-Microbiological analyses at 26 + 10 weeks and 26 + 26 weeks

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/02/12
  •   45
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

- Insufficient bone ridge width at the recipient site for implant placement
- Sufficient bone height at the recipient site for implant placement
- extraction of non-retainable tooth/ teeth (refers to groups receiving autogenous tooth roots)
- Healthy oral mucosa, at least 3 mm keratinized mucosa

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Exclusion Criteria

- Inflammatory and autoimmune disease of oral cavity
- Uncontrolled HbA1c (> 7%) in diabetes patients
- History of malignancy requiring chemotherapy or radiotherapy within the past five years
- Concurrent or previous radiotherapy of head area
- Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy
- Smokers
- Pregnancy or lactating women

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Addresses

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    • Poliklinik für Zahnärztliche Chirurgie und Aufnahme, Universitätsklinikum Düsseldorf
    • Mr.  Prof. Dr.  Frank  Schwarz 
    • Moorenstrasse 5
    • 40225  Düsseldorf
    • Germany
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    • Poliklinik für Zahnärztliche Chirurgie und Aufnahme, Westdeutsche Kieferklinik, Universitätsklinikum Düsseldorf
    • Mr.  Prof. Dr. med. dent.  Frank  Schwarz 
    • Moorenstrasse 5
    • 40225  Düsseldorf
    • Germany
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    • Poliklinik für Zahnärztliche Chirurgie und Aufnahme, Westdeutsche Lieferklinik, Universitätsklinikum Düsseldorf
    • Ms.  Sara  Civale 
    • Moorenstrasse 5
    • 40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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