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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00018875 |
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Date of registration:
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03/01/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A MULTICENTER RANDOMIZED CONTROLLED STUDY COMPARING EARLY IMPLANT PLACEMENT TO ALVEOLAR RIDGE PRESERVATION FOR SINGLE TOOTH REPLACEMENT IN THE ANTERIOR AREA
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Scientific title:
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A MULTICENTER RANDOMIZED CONTROLLED STUDY COMPARING EARLY IMPLANT PLACEMENT TO ALVEOLAR RIDGE PRESERVATION FOR SINGLE TOOTH REPLACEMENT IN THE ANTERIOR AREA - RP vs EP |
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Date of first enrolment:
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11/02/2020 |
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Target sample size:
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46 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00018875 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: prevention
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Phase:
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4
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Countries of recruitment
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Belgium
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Switzerland
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Contacts
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Name:
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Daniel
Thoma |
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Address:
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Plattenstrasse 11
8032
Zürich
Switzerland |
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Telephone:
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0041 44 634 04 04 |
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Email:
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research.rzm@zzm.uzh.ch |
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Affiliation:
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Clinic of Reconstructive DentistryCenter of Dental MedicineUniversity Zurich |
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Name:
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Daniel
Thoma |
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Address:
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Plattenstrasse 11
8032
Zürich
Switzerland |
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Telephone:
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0041 44 634 04 04 |
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Email:
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research.rzm@zzm.uzh.ch |
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Affiliation:
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Clinic of Reconstructive DentistryCenter of Dental MedicineUniversity Zurich |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Periodontally healthy individuals with at least 20 years of age
2. Good oral hygiene (BOP & PlI = 20%)
3. Patients with a failing single tooth in the maxilla and mandible, from second premolar to second premolar
4. At least 50% of the buccal bone plate intact after tooth extraction
5. At least one neighboring natural tooth
6. Presence of antagonist
7. Capability to comply with the study procedures
8. Informed Consent as documented by signature
Exclusion criteria: 1. Pregnant or lactating women
2. Known or suspected non-compliance, drug or alcohol abuse
3. Smokers (>10 cigarettes/day)
4. Systemic or local conditions presenting a contraindication to implant treatment
5. Currently taking drugs that influence bone metabolism
6 .Use of bisphosphonates in the last 4 years
7. History of malignancy, radiotherapy or chemotherapy for malignancy in the past 5 years
Age minimum:
20 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diseases of oral cavity, salivary glands and jaws
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K00-K14
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K00-K14
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Intervention(s)
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Group 1: Ridge preservation
(placement of the implant 5 months after tooth extraction and filling with biomaterials)
Group 2: Early Implant Placement (Placement of the implant 2 months after tooth extraction and together with biomaterials)
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Primary Outcome(s)
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The primary outcome will be contour changes (mm) at the buccal aspect of the extraction site from pre-tooth extraction (baseline) to 5 months later by volumetric analysis.
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Secondary Outcome(s)
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• profilometric outcomes (horizontal changes) at screening, T0, T1, T2, T3, T4, T5, T6.
• clinical parameters (probing depth, bleeding on probing, plaque index, keratinized mucosa) at screening, T3, T4, T5, T6 by using a dental probe
• aesthetic (PES, WES) at screening, T3, T4, T5, T6 by dentist's score
• marginal bone level and buccal bone thickness at T0, T2, T3, T6 by radiographic methods
•i mplant survival at T3, T4, T5, T6 by observing whether the implant is in place or not
• patient-reported outcome measures at T0, T1, T2, T3, T4, T5, T6 by questionnaires
• costs at T3, T4, T5 and T6.
• need for additional Guided Bone Regeneration at T1, T2.
• need for an additional soft tissue grafting procedure at T2.
• Dentist's VAS score for ease of treatment for the dentist at T0, T1, T2.
• Dentist's VAS for Treatment Satisfaction for the dentist at T3,T4,T5,T6
• Technical parameters at T3, T4,T5,T6 by using USPHS criteria
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Source(s) of Monetary Support
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ITIFoundation
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Ethics review
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Status: Approved
Approval date: 21/11/2019
Contact:
info.kek@kek.zh.ch
Kantonale Ethikkommission Zürich
(+41)43-2597970
info.kek@kek.zh.ch
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