Immediate implant with bone and connective tissue grafting for upper front teeth
A Clinical Study on Immediate Implant Placement in the Premaxilla With Flapless Guided Surgery, Hard and Soft Tissue Augmentation and Immediate Provisionalization
This study will test whether flapless guided immediate implants with socket grafting, a connective tissue graft, and an immediate provisional crown work well for adults who need an upper front tooth removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | University Ghent Academic / other |
| Locations | 2 sites (Ghent, East Flanders and 1 other locations) |
| Trial ID | NCT07080710 on ClinicalTrials.gov |
What this trial studies
Participants receive a preoperative 3D radiograph and an intra-oral digital impression to design a flapless guided surgical guide. The tooth is extracted atraumatically, an implant is placed using the guide, the socket is grafted with collagen-enriched deproteinized bovine bone mineral, and a connective tissue graft from the palate is sutured onto the buccal mucosa. A healing abutment is placed and replaced by a provisional crown two days later. Outcomes measured include buccal bone thickness (primary at 1 mm below the implant shoulder), additional bone levels at 3 and 5 mm, marginal bone loss, peri-implant health, soft tissue changes, patient pain and esthetic ratings, and complications up to five years, with comparisons between intact and non-intact sockets.
Who should consider this trial
Good fit: Adults aged 20 or older who need extraction of a maxillary incisor, canine, or premolar, have good oral hygiene, at least 3 mm of apical or palatal bone for primary stability, and can give informed consent are ideal candidates.
Not a fit: Patients who smoke, have uncontrolled systemic disease, active periodontal or untreated caries, insufficient apical bone, failing teeth outside the bone envelope, or who are pregnant are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could better preserve buccal bone and soft tissue, improving esthetic outcomes and allowing immediate temporary crowns after extraction.
How similar studies have performed: Previous clinical reports of immediate implant placement with socket grafting and connective tissue grafts have shown promising esthetic and tissue-preserving results, though long-term comparative evidence is 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 one or more incisors, cuspids or premolars in the maxilla that need 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 alveoli as assessed on a three-dimensional radiograph to ensure primary implant stability * Written informed consent. Exclusion Criteria: * Pregnancy (will be explicitly asked) * Systemic diseases * Smoking; suppuration * \> 1 mm gingival asymmetry between the failing teeth and contralateral teeth * Failing teeth outside the bone envelop as assessed on a three-dimensional radiograph * Untreated periodontal disease; untreated caries lesions.
Where this trial is running
Ghent, East Flanders and 1 other locations
- Ghent University — Ghent, East Flanders, Belgium (Recruiting)
- Bv Dr. Cosyn — Zottegem, 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.