Randomized clinical study to evaluate the effects of sequential gingival contour adjustment using a fixed temporary prosthesis following soft tissue augmentation around implants with Fibro-Gide (collagen matrix).

Randomized controlled trial evaluating changes of periimplant mucosal dimension after soft tissue augmentation with Fibro-Gide® and progressive mucosal contouring with provisionalization.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010407

Enrollment

Registered

2025-04-11

Start date

2024-12-18

Completion date

Unknown

Last updated

2025-05-07

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

Conditions

None listed

Interventions

Procedure/Surgery : - Total: 30 people (30 from Yonsei University Department of Periodontology) - Experimental group (Test group

15 people): THAB (diameter 2.0 mm) HA. Secured, replaced with a wider diameter H.A after 1m - Control group (Control group

15 people): Secured with a wider diameter H.A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 19 years and older 2. Patients scheduled for primary and secondary surgeries of implants connecting the healing abutment 3. Patients expected to require implant placement in the maxillary anterior region and premolar area, as well as soft tissue augmentation surgery

Exclusion criteria

Exclusion criteria: 1. Patients with uncontrolled periodontal disease 2. Patients with uncontrolled metabolic diseases such as diabetes 3. Smokers (more than 10 cigarettes per day) 4. Patients with a history of radiation therapy to the head and neck area and chemotherapy 5. Pregnant and breastfeeding patients 6. Patients with a history of taking medications that may induce MRONJ (such as Bisphosphonates, Denosumab, etc.) within the last 4 months

Design outcomes

Primary

Measure	Time frame
Thickness of the buccal mucosa	—

Secondary

Measure	Time frame
The height of the buccal mucosa;Clinical indicators (buccal mucosal recession, probing depth, bleeding on probing);Radiological indicators (changes in marginal bone height and marginal bone thickness);Postoperative side effects and complications;Patient-Centered Outcome Reporting;Convenience of clinicians;Profilometric analysis	—

Countries

Korea, Republic of

Contacts

Public ContactPark Jin Yung

Yonsei University Health System, Dental Hospital

jypark87@yuhs.ac+82-2-2228-3197

Outcome results