Clinician- and patient-reported outcome measures (ClinROs/PROMs) fol-lowing implant placement with open vs submerged healing of native collagen membranes (BioGide® Compressed)

Clinician- and patient-reported outcome measures (ClinROs/PROMs) fol-lowing implant placement with open vs submerged healing of native collagen membranes (BioGide® Compressed) - Open healing /Compressed

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040314

Enrollment

Registered

2026-05-11

Start date

2026-05-31

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This pilot study aims to investigate the ease of performing open healing (exposed implant abutment) after implant placement compared to the standard procedure where the implant is submerged.

Interventions

Group 1: Test group: The implant and the bone graft material heal by open healing (no closure after fixation of the membrane) Group 2: Control group: The implant and the bone graft material heal by su

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Informed Consent signed by the subject • Need for a 1-piece implant in the posterior region (premolar or molar) in the mandible/maxilla • At least 1 neighbouring tooth or implant • Presence of at least 2mm width of keratinised mucosa pre-implantation • Periodontally healthy patients (periodontal probing depths ? 4mm) (full mouth) • Good oral hygiene (Plaque Control Record <25%; (O'Leary et al., 1972)) • Adequate control of inflammation (full mouth bleeding on probing <25%; (Ainamo & Bay, 1975)) • Capability to comply with the study procedures

Exclusion criteria

Exclusion criteria: • Pregnant or lactating women • Smokers (>10 cigarettes/day) • Currently taking drugs that influence bone metabolism • Need for soft tissue augmentation • Known or suspected non-compliance, drug or alcohol abuse • Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject

Design outcomes

Primary

Measure	Time frame
Primary endpoint: Ease of treatment by NRS based questionnaire directly after implant placement	—

Secondary

Measure	Time frame
Secondary endpoints: • Duration of surgery • Wound healing index (wound closure) at suture removal • Swelling at suture removal • PROMs: pain during the first 24h after surgery, patient’s satisfaction, OHIP-14 • Clinical measurements (BOP, PI, PD, width of keratinised tissue) at Baseline, 6 months, 1- and 3-years • Implant survival at Baseline, 6 months, 1- and 3-years • Marginal bone level changes between Baseline and the 1y and 3y follow-ups	—

Measure

Time frame

Secondary endpoints: • Duration of surgery • Wound healing index (wound closure) at suture removal • Swelling at suture removal • PROMs: pain during the first 24h after surgery, patient’s satisfaction, OHIP-14 • Clinical measurements (BOP, PI, PD, width of keratinised tissue) at Baseline, 6 months, 1- and 3-years • Implant survival at Baseline, 6 months, 1- and 3-years • Marginal bone level changes between Baseline and the 1y and 3y follow-ups

—

Countries

Switzerland

Contacts

Public ContactMarina Siegenthaler

Zahnarzt Praxis Grimm Zahnärzte

marina.siegenthaler@grimmzahnaerzte.ch+41 44 725 42 42

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026