Mucograft Seal in ARP Follow-up

ConditionDental Implant

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorErasmus Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients previously included in the above mentioned RCT.

Disqualifiers

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.

Trial population

All patients were included in a prospective randomized clinical trial comparing alveolar ridge preservation with a xenograft and a collagen matrix or a free connective tissue graft versus spontaneous healing (MEC-2015-016;NL49965.078.14).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

buccal marginal gingival level

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?

Time frame

5 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erasmus Medical Center

Lead sponsor

Institut Straumann AG

Collaborator

Source ClinicalTrials.gov

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