Trial document




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  DRKS00010106

Trial Description

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Title

Comparison of two different mucosal closure techniques after tooth extraction in high risk patients with antiresortive medication intake - a prospective, randomized, blinded feasebility study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Intake of medication that suppresses bone remodeling (as bisphosphonates or denosumab) is common for malignant diseases with bone metastasis. The unwanted side effect of this medications is the necrosis of the jaw (jaw bone loses its vitality). In order to prevent this side effect, possible infection side are prophylacticly eliminated (teeth are extracted) following guidelines. Amongst others good wound closure is of major importance. Therefore, the goal of this study is to find out whether there is a difference in therapeutic success between two different mucosal closure techniques after tooth extraction in high risk patients taking these bone remodeling suppressing medications. Data is gained be regular clinical and radiologic examinations. The study is designed over a 12 month period. All examinations are part of a already existing standardized protocol in patients taking medications that suppress bone remodeling.

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Brief Summary in Scientific Language

This study presents a multicentre, randomised, controlled, blinded, clinical feasibility trial with two parallel study arms to demonstrate that sub-periostal flap elevation for plastic wound closure is superior to the epi-periostal flap elevation for plastic wound closure after tooth extractions in patients receiving antiresorptive therapy with respect to postoperative wound dehiscence and the incidence of the medication related osteonecrosis of the jaw.
The primary hypothesis is that the dehiscence rate and the incidence of the medication related osteonecrosis of the jaw in patients undergoing tooth extractions is clinically relevant higher for patients treated with the epi-periostal technique compared the sub-periostal technique. The primary efficacy endpoint is defined as the occurrence of medication related osteonecrosis of the jaw eight weeks after surgery. Several secondary endpoints are evaluated including the loss of mucosal integrity, detection of medication related osteonecrosis of the jaw early lesions (using fluorescence techniques and histopathological workups), radiologic signs for medication related osteonecrosis of the jaw early lesions as wells as participant health related qulity of life, measured by EQ-5D (standardised measure of health outcome). The entire trial is planned for 12 months, with an enrollment of 40 patients within six months and six months of follow up.
The results of this preliminary study will be used for the power calculation of a confirmatory phase III trail with the goal to produce evidence based data usable for future preventive medication related osteonecrosis of the jaw treatment guidelines.

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Organizational Data

  •   DRKS00010106
  •   2016/03/30
  •   [---]*
  •   yes
  •   Approved
  •   S-088/2016, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   K10.28 -  [generalization K10.2: Inflammatory conditions of jaws]
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Interventions/Observational Groups

  •   Arm 1- Subperiosteal wound closure after tooth extraction under antiresorptive medication >3 years
  •   Arm 2- Epiperiosteal wound closure after tooth extraction under antiresorptive medication >3 years
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Occurrence of a medication related osteonecrosis of the jaw (MRONJ) eight weeks after operation (Defined by the AAOMS criteria and the german association of maxilla facial surgery)

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Secondary Outcome

1. Postoperative loss of mucosal integrity with/without infection signs (reddening, swelling, pus) 2. Depiction of MRONJ early lesions by loss of auto-fluorescence of the bone 3. Depiction of MRONJ early lesions by histopathological work ups 4. radiologic signs of MRONJ early lesions 5. Quality of life using the EQ-5D scoresheet
All secondary endpoints (1-5) are aquired to the following measuring points:
10 days (T1), 30 days (T2), 8 weeks (T3), 4 months (T4), 6 months (T5), 1 year (T6) after operation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2016/08/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with malignant disease and antiresorptive medication intake planed for preventive tooth extraction

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Exclusion Criteria

1. Previous history of a radiation to the head neck region 2. Known metastasis of the jaw 3. exposed bone in the operation field 4. Existing diagnosis MRONJ in the operation field

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Addresses

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    • Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
    • Mr.  Dr. Dr.  Oliver  Ristow 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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    • Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
    • Mr.  Dr. Dr.  Oliver  Ristow 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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    • Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
    • Mr.  Dr. Dr.  Oliver  Ristow 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
    • Mr.  Dr. Dr.  Oliver  Ristow 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.