Mucograft Seal in ARP Follow-up

NCT05663385 | Recruiting DMC

• 1 other identifier: NL82943.078.22
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implant

Outcome Measures

Primary Outcomes (1)

• 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?

  5 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• All patients previously included in the above mentioned RCT.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Institut Straumann AG: collaborator

Study Sites (1)

Erasmus Mc

Rotterdam, 3015gd, Netherlands

RECRUITING

Central Study Contacts

Justin Pijpe, MD DDS PhD MSc

CONTACT

+31641397764; j.pijpe@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistent Professor

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: April 16, 2024
• Primary Completion: August 14, 2025
• Study Completion: October 1, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)