Immediate upper-front tooth implants with bone augmentation, with or without a connective tissue graft

Effectiveness of Hard Tissue Augmentation With or Without Connective Tissue Graft Following Immediate Dental Implants in the Esthetic Zone: A Randomized Controlled Study

This test sees if adding a connective tissue graft to bone augmentation improves appearance, clinical outcomes, and X-ray findings after placing an immediate single-tooth implant in the upper front teeth.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Baghdad (other)
• Drugs / interventions: radiation
• Locations: 1 site (Baghdad, Rusafa)
• Trial ID: NCT07333534 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial will enroll patients needing an immediate single-tooth implant in the maxillary esthetic zone and randomly assign them to receive either bone augmentation alone or bone augmentation plus a connective tissue graft (CTG). All participants will receive immediate implant placement with a requirement for adequate primary stability, and clinicians will collect esthetic, clinical, and radiographic outcome measures. Follow-up visits will include esthetic scoring, soft-tissue and implant examinations, and radiographic assessment of bone levels over the healing period. The goal is to determine whether adding CTG leads to superior soft-tissue contour and long-term esthetic stability compared with bone grafting alone.

Who should consider this trial

Good fit: Ideal candidates are adults with a non-restorable maxillary incisor, canine, or first premolar bounded by natural teeth who have sufficient apical and palatal bone (>4 mm) and can achieve primary implant stability of ≥35 N·cm.

Not a fit: Patients with acute periapical infection, labial bone plate dehiscence after extraction, uncontrolled systemic conditions affecting bone healing, heavy smoking, uncontrolled periodontal disease, pregnancy, decision-making impairment, or prior head/neck radiation are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, adding a connective tissue graft could yield better gum contour and esthetic appearance and potentially more stable long-term results for immediate upper-front implants.

How similar studies have performed: Previous studies have reported that connective tissue grafts can increase soft-tissue thickness and improve esthetic scores in some immediate implant cases, but findings are mixed and context-dependent.

Eligibility criteria

Inclusion Criteria:

* Patients with a non-restorable tooth or a remaining root without signs of acute infection in the maxillary esthetic zone.
* The failing tooth is an incisor, canine or first bicuspid in the maxilla bounded by natural sound teeth.
* Sufficient bone (\>4 mm) apically and palatally to allow for proper implant positioning with sufficient primary stability (≥35 N cm).
* Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.

Exclusion Criteria:

* Patients with systemic conditions affecting bone healing (e.g., uncontrolled diabetes).
* Teeth with current acute periapical infection.
* Dehiscence of the labial (facial) bone plate after extraction.
* Signs of uncontrolled periodontal disease.
* Heavy smokers and vulnerable groups (pregnant females and decision-impaired individuals).
* History of head and neck radiation therapy.

Where this trial is running

Baghdad, Rusafa

• University of Baghdad/ College of Dentistry/ Department of Oral and Maxillofacial surgery/ Implant Unit — Baghdad, Rusafa, Iraq (RECRUITING)

Study contacts

• Study coordinator: Khalid Khalid, Bachelor of Dental Surgery

Conditions: Dental Implant, immediate implant, maxillary esthetic zone, CTG, jumping gap, bone augmentation