How the implant-to-bone gap affects labial bone thickness after replacing a broken upper front tooth

Clinical and Radiographic Evaluation of Change in Labial Bone Thickness in Immediate Implant Placement In Maxillary Esthetic Zone Comparing a Jumping Gap of Less Than 2 mm to Equal or More Than 2 mm: A Non-randomized Clinical Trial

This test will see if the horizontal gap between an immediate implant and the socket wall changes the labial bone thickness and affects soft-tissue esthetics and patient satisfaction in adults needing a single upper front tooth replacement.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Cairo University (other)
• Drugs / interventions: radiation
• Locations: 1 site (Cairo)
• Trial ID: NCT07509476 on ClinicalTrials.gov

What this trial studies

Patients with a bounded non-restorable upper anterior tooth will receive immediate implant placement using a surgical guide and will be assigned to one of two groups based on the horizontal defect distance (jumping gap) either <2 mm or ≥2 mm. Labial bone thickness will be measured preoperatively on CBCT and confirmed at surgery, and patients will return for clinical checks and radiographs every three months up to one year. The study compares changes in labial bone thickness, soft-tissue quality, esthetic outcomes, and patient-reported satisfaction between the two gap groups. The trial is conducted at the Department of Periodontology, Faculty of Dentistry, Cairo University, with participants recruited from its outpatient clinic.

Who should consider this trial

Good fit: Adults aged 21–65 with a single bounded non-restorable upper anterior tooth (FDI 15–25), good oral hygiene (BoP ≤ 10%), remaining labial bone ≥ 1 mm on CBCT, and willing to attend one-year follow-up visits.

Not a fit: Patients with active infection at the tooth site, existing labial bone fenestration or dehiscence, large cysts or related pathological lesions, or insufficient labial bone (<1 mm) are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the results could guide clinicians on an optimal implant-to-socket gap to better preserve labial bone and improve esthetic outcomes and patient satisfaction.

How similar studies have performed: Related studies have explored jumping gap management and immediate implant protocols, but evidence about the optimal horizontal gap remains limited and inconclusive.

Eligibility criteria

Inclusion Criteria:

1. Patients with a bounded single non-restorable upper tooth in the anterior maxilla (15-25) FDI (El Ebiary et al., 2023b)
2. Patients with an age range of 21 to 65 years old (Levine et al., 2022)
3. Patients with good oral hygiene with BoP ≤ 10 % (Chapple et al., 2018)
4. Compliant patients willing to follow up to one year.
5. Remaining labial bone thickness ≥ 1mm measured on C.B.C.T. and confirmed on the day of surgery after tooth extraction and before final implant placement.

Exclusion Criteria:

1. The presence of acute/active infection related to the non-restorable tooth (Block et al., 2009) cited in (Soegiantho et al., 2023)
2. Presence of labial bone defect as fenestration/dehiscence (Crespi et al., 2008) cited in (Soegiantho et al., 2023)
3. Large cyst or pathological lesion related to the tooth (Tallarico et al., 2016-2017) cited in (Soegiantho et al., 2023); (Morton, Wismeijer, Chen, Hamilton, Wittneben, Casentini, Gonzaga, Lazarin, Martin, Molinero-Mourelle, et al., 2023)
4. History of radiation to the maxilla (Cannizzaro et al., 2010) cited in (Soegiantho et al., 2023)
5. History of bisphosphonate therapy or other anti-resorptive agents (Cannizzaro et al., 2010) cited in (Soegiantho et al., 2023)
6. Uncontrolled systemic or metabolic disease. (Cecchinato et al., 2015) cited in (Soegiantho et al., 2023)
7. Patients with parafunctional habits or active periodontitis (Cannizzaro et al., 2010) cited in (Soegiantho et al., 2023) 8- Tobacco abuse (\>10 cigarettes per day) (Canullo et al., 2010) cited in (Soegiantho et al., 2023)

9- Alcohol abuse (Block et al., 2009) cited in (Soegiantho et al., 2023)

Where this trial is running

Cairo

• Cairo University — Cairo, Egypt (RECRUITING)

Conditions: Guided Immediate Implant Placement, Jumping Gap, Labial Bone Thickness Change, Broken Down Tooth Rehabilitation, Immediate implant placement, Customized healing abutment, Jumping gap, Surgical guide