Guided bone regeneration of peri-implant defects with particulate versus soft-type block bone substitutes. A randomized controlled, single blinded clinical trial

Phase 4

Recruiting

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

Registration Number: DRKS00020222

Lead Sponsor: Clinic of Reconstructive DentistryCenter of Dental MedicineUniversity of Zürich

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 64

Inclusion Criteria

Patients, in need of at least one implant with an expected peri-implant bone dehiscence = 2 mm of apico-coronal dimension in the maxilla or mandible (excl. molars)
-primary implant stability assessed at implant placement
-no need of soft tissue grafting after implant placement
-tooth extraction performed = 4 months in advance
-possibly performed soft tissue grafting = 2 months in advance
-Presence of one adjacent tooth at the implant site;
-Presence of antagonist;
-Adequate oral hygiene (Bleeding on probing <20%; Plaque index <20%);
-Capability to comply with the study procedures
-Signed Informed Consent Form

Exclusion Criteria

-Ridge preservation procedure after tooth extraction performed
-Pregnant or lactating women;
-Known or suspected non-compliance, drug or alcohol abuse
-Smokers (>10 cigarettes/day including e-cigarettes)
-Currently taking drugs that influence bone metabolism
-Use of bisphosphonates in the last 4 years
-Systemic or local conditions presenting a contraindication to implant treatment
-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
Change of horizontal bone thickness at the level of the implant shoulder of the augmented region between baseline (implant placement) and 6 months visit, measured by CBCT

Secondary Outcome Measures

Name	Time	Method
-marginal bone level (implant shoulder to first bone-to-implant-contact) at baseline, 6 months, 1 year, 3 and 5 years, by radiographs<br><br>- Implant survival at 6 months, 1 year, 3 and 5 years by visual observation<br><br>- horizontal bone thickness at the level of the implant shoulder of the augmented area at 6 months, 1 year, 3 and 5 years by CBCT<br><br>- vertical defect fill at implant placement, at 6 months and at 5 years by radiographs<br><br>- soft tissue volume at the area of interest at implant placement, at 6 months, 1 years, 3 and 5 years by volumetric analysis of the digital impressions<br><br>- PD, REC and KT, PI, BOP, MML at Baseline, 6 months, 1 year, 3 and 5 years) by probing<br><br>- PES: evaluator rating at final reconstruction, 1 year, 3 and 5 years<br> <br>-Patient reported outcomes (OHIP questionnaire, general rating of outcome) at 6 months, final reconstruction, 1 year,3 and 5 years<br><br>-Prosthetic outcomes by USPHS