A MULTICENTER RANDOMIZED CONTROLLED STUDY COMPARING EARLY IMPLANT PLACEMENT TO ALVEOLAR RIDGE PRESERVATION FOR SINGLE TOOTH REPLACEMENT IN THE ANTERIOR AREA

Phase 4

• Conditions: K00-K14; Diseases of oral cavity, salivary glands and jaws

• Registration Number: DRKS00018875
• Lead Sponsor: Clinic of Reconstructive DentistryCenter of Dental MedicineUniversity Zurich

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
• profilometric outcomes (horizontal changes) at screening, T0, T1, T2, T3, T4, T5, T6.<br>• clinical parameters (probing depth, bleeding on probing, plaque index, keratinized mucosa) at screening, T3, T4, T5, T6 by using a dental probe<br>• aesthetic (PES, WES) at screening, T3, T4, T5, T6 by dentist's score<br>• marginal bone level and buccal bone thickness at T0, T2, T3, T6 by radiographic methods<br>•i mplant survival at T3, T4, T5, T6 by observing whether the implant is in place or not<br>• patient-reported outcome measures at T0, T1, T2, T3, T4, T5, T6 by questionnaires<br>• costs at T3, T4, T5 and T6.<br>• need for additional Guided Bone Regeneration at T1, T2.<br>• need for an additional soft tissue grafting procedure at T2.<br>• Dentist's VAS score for ease of treatment for the dentist at T0, T1, T2.<br>• Dentist's VAS for Treatment Satisfaction for the dentist at T3,T4,T5,T6<br>• Technical parameters at T3, T4,T5,T6 by using USPHS criteria<br><br>