Three soft-tissue methods for single immediate implants in the upper front teeth
A Three-arm Randomized Controlled Trial Comparing Transmucosal Augmentation Techniques in Immediate Implant Placement
This will see which of three soft-tissue grafting methods best prevents buccal gum loss for adults receiving a single immediate implant in the upper front teeth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | University Ghent Academic / other |
| Locations | 1 site (Ghent, East Flanders) |
| Trial ID | NCT06820489 on ClinicalTrials.gov |
What this trial studies
This is a randomized, three-arm trial that enrolls 54 adults receiving a single immediate implant in the anterior maxilla, with participants randomly assigned to conventional connective tissue graft (C-CTG), scarf CTG (S-CTG), or the dual‑zone (DZ) approach. All participants receive socket grafting and immediate implant placement; the only difference between groups is the transmucosal soft‑tissue augmentation technique. Outcomes are measured with low‑dose CBCT scans and clinical exams, with the primary outcome defined as successful regeneration 1 mm below the implant shoulder based on superimposed CBCTs; outcome assessors are blinded. Secondary outcomes include clinical parameters, hard- and soft‑tissue dimensional changes, esthetic scores, and patient‑reported pain and medication use.
Who should consider this trial
Good fit: Adults (≥20) with good oral hygiene who need extraction of a single upper front tooth and who have adequate apical/palatal bone and an intact or minimally dehiscent buccal bone are ideal candidates.
Not a fit: Patients who smoke, have uncontrolled systemic disease, active infection, untreated periodontal disease, >1 mm gingival asymmetry, or inadequate bone for primary stability are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If one method performs better, patients could have less buccal tissue loss after immediate implants, improving esthetics and long‑term implant support.
How similar studies have performed: Previous work shows connective tissue grafting and dual‑zone approaches can reduce soft‑tissue loss and improve esthetics, but direct randomized comparisons of these three specific techniques are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 20 years old * Good oral hygiene defined as full-mouth plaque score ≤ 25% * Presence of an incisor, cuspid or premolar in the maxilla that needs to be extracted for any reason with at least one neighboring tooth present * At least 3 mm bone available at the apical or palatal aspect of the alveolus as assessed on CBCT to ensure primary implant stability * Intact buccal bone wall (type I) or limited buccal bone dehiscence (type IIa or IIb) at the time of extraction * Written informed consent. Exclusion Criteria: * Pregnancy * Systemic diseases * Smoking; suppuration * \> 1 mm gingival asymmetry between the failing and contralateral tooth * Untreated periodontal disease * Untreated caries lesions.
Where this trial is running
Ghent, East Flanders
- Ghent University Hospital — Ghent, East Flanders, Belgium (Recruiting)
Study contacts
- Study coordinator: Véronique Christiaens, PhD
- Email: vchristi.christiaens@UGent.be
- Phone: 09/332 40 17
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.