Clinical trial · Interventional
Antiresorptive Drug Continuation Compared With Drug Holiday in Cancer Patients Needing Tooth Extraction
Antiresorptive Drug Continuation Compared With Drug Holiday in Cancer Patients Needing Tooth Extraction - A Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this trial is to evaluate high-dose antiresorptive drug holiday related to tooth extraction with primary mucosal closure (surgical extraction) including how a drug holiday affects the health related quality of life. Research question: Does a drug holiday have any influence on health related quality of life or the incidence of developing osteonecrosis of the jaw after surgical tooth extraction? The investigators hypothesize that a drug holiday 1 month before to 3 months after surgical tooth extraction in cancer patients do not influence the development of osteonecrosis of the jaw and may even affect the health related quality of life negatively.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteonecrosis Due to Drugs, Jaw | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Continuation of antiresorptives in relation to tooth extraction (surgical tooth removal) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cancer patients, randomized A
- description
- Patients in high-dose antiresorptives with bone metastases
- interventionNames
- Other: Continuation of antiresorptives in relation to tooth extraction (surgical tooth removal)
- type
- NO_INTERVENTION
- label
- Cancer patients, randomized B
- description
- Drug Holiday as standard operation procedure
Primary outcomes (2)
- measure
- Development of osteonecrosis of the jaw (ONJ) or incomplete healing at 3 months follow-up
- timeFrame
- 3 months follow-up
- description
- The outcome assessor has 3 options for registration related to ONJ occurrence: * Complete healing = mucosal covering = no sign of ONJ, defined as complete wound healing; Intact mucosa, that is total mucosal covering over the tooth extraction area. * Incomplete healing = presence of fibrin covering partly or over all mucosal operation area; Defined as the presence of fibrin at the surface of the operation area, thus still being a wound. * ONJ present, defined according to the AAOMS position paper 2014 (4), all three items have to be present: 1. Current or previous treatment with antiresorptive agents. 2. Exposed bone or bone that can be probed through an extraoral or intraoral fistula that has persisted for longer than 8 weeks. 3. No history of radiation therapy to the jaws or obvious metastatic disease to the jaws.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients eligible for the trial must comply with all of the following at randomization: * Patients aged 18 years or older. * Patients with malignant disease (breast or prostate cancer, multiple myeloma) and metastases to the skeleton. * Patients present high dose/intravenous antiresorptive therapy for at least 1 month. * Patients who need tooth extraction. Indications for extraction include root fracture, endodontic failure, severe periodontal disease, non-restorable caries and teeth with a poor prognosis or at high risk of infection, complications. * Patients who have an ECOG (Eastern Cooperative Oncology Group) score \< 2 (30). Definition of ECOG 0. Fully active, able to carry on all pre-disease performance without restriction. 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature e.g., light house work, office work. 2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of walking hours. 3. Capable of only limited selfcare, confined to bed or chair more than 50% of walking hours. 4. Completely disabled. Cannot carry on selfcare. Totally confined to bed or chair. * Signed informed content. Exclusion Criteria: * Patients must not have received radiation therapy to the jaws. * Patients must not have exposed bone, or signs of non-exposed bone. * Patients previous diagnosed with ONJ. * Patients who are unable to cooperate or too ill to complete the experiment. * Lack of signed informed consent.
References
Publications (0)
Data not yet available