Collagen matrix or palatal graft versus natural healing for preserving the front-tooth ridge
Official title: 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
Run by Erasmus Medical Center · NCT05663385 · Data updated 2026-11-12
This follow-up will see if using a collagen matrix or a palatal connective tissue graft with a bone xenograft helps preserve gum and bone around a single front-tooth implant better than letting the socket heal on its own in people who had early implant placement.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rotterdam) |
| Status | Recruiting |
| Started | April 16, 2024 |
| Main results expected | August 14, 2025 |
| Study ends | October 1, 2025 |
| Registry record updated | August 12, 2025 |
| Trial ID | NCT05663385 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults who participated in the original randomized trial of ARP versus spontaneous healing and who did not receive head-and-neck radiotherapy or current chemotherapy and can maintain basic oral hygiene.
✕Probably not a fit
People who had different implant procedures (e.g., posterior or multiple-tooth replacements), received radiotherapy/chemotherapy during follow-up, or cannot perform basic oral hygiene are unlikely to benefit from this follow-up.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective 5-year observational follow-up of patients previously enrolled in a randomized comparison of alveolar ridge preservation (ARP) techniques versus spontaneous healing prior to early implant placement in the anterior maxilla. Participants received either a xenograft plus a collagen matrix or a xenograft plus a free palatal connective tissue graft, or were managed with spontaneous healing, and will be re-examined up to five years after functional loading. The primary outcome is the midfacial mucosal (buccal marginal gingiva) level, with secondary outcomes including PES/WES esthetic scores, complications, implant survival and success, plaque index, and modified bleeding index. No new interventions are planned; the study documents long-term clinical, esthetic, and patient-reported outcomes at Erasmus Medical Center.
Why it matters
Potential benefit: If successful, the results could show which socket management approach best preserves gum and bone long-term and so improve esthetic outcomes and implant stability for front-tooth replacements.
How similar studies have gone: Prior work (including the original RCT and reports of socket-seal techniques) showed good short-term esthetic outcomes and similar results up to one year, but long-term (5-year) comparative data are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Erasmus Mc
Rotterdam, Netherlands Recruiting
Study contacts
- Study coordinator: Justin Pijpe, MD DDS PhD MSc
- Email: j.pijpe@erasmusmc.nl
- Phone: +31641397764
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.