- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05663385
Mucograft Seal Follow-up
Alveolar Ridge Preservation With a Xenograft (Bio-Oss® Collagen) and a Collagen Matrix (Mucograft® Seal) or a Free Connective Tissue Graft Versus Spontaneous Healing:A 5-year Follow up
Rationale: Early implant placement with alveolar ridge preservation (ARP) using either a collagen matrix or a palatal graft rendered similar esthetic, clinical and PROMs to early implant placement without ARP, up to 1 year after functional loading.
Objective: The aim of this study is to evaluate esthetic and clinical outcomes and patient satisfaction following single-tooth replacement in the anterior maxilla in patients treated with a xenograft and a collagen matrix or a free connective tissue graft versus spontaneous healing 5 years after loading
Study design: prospective observational study with 5-year follow-up
Intervention (if applicable): not applicable
Main study parameters/endpoints: Comparison of the level of the buccal marginal gingiva (midfacial mucosa level) between ARP versus spontaneous healing
Secondary parameters/endpoint: Peri-implant esthetic score (PES) and white esthetic score (WES), complications, implant survival; and success, Plaque Index, Modified bleeding index, Gingival Index, Probing Depth, PROMs, bone and soft tissue volumetric dimensional changes.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients previously included in the above mentioned RCT.
Exclusion Criteria:
- Patients treated with radiotherapy during follow-up in the head-and-neck region or current chemotherapy; disability (mental and/or physical) to maintain basic oral hygiene procedures.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
buccal marginal gingival level
Time Frame: 5 year
|
1. Is the buccal marginal gingival level (midfacial mucosa level) of implants treated post-extraction with a bone substitute material (BioOss® Collagen) and a collagen matrix (Geistlich Mucograft® Seal) (Group A) or covered with a palatal graft (Group B) more favorable then the buccal marginal gingiva in spontaneous healing (Group C) up to 5 year after functional loading?
|
5 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NL82943.078.22
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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