Alveolar Bone Loss* / Therapy, Tooth Loss in the Anterior Maxilla
Conditions
Keywords
Immediate dental implant, Beta-tricalcium phosphate, Bone graft, Osseointegration, Implant stability
Brief summary
This randomized controlled trial evaluated whether grafting the peri-implant "jumping gap" with injectable β-tricalcium phosphate (β-TCP) improves outcomes after immediate implant placement in sites where the horizontal gap between the implant surface and the surrounding socket wall exceeds 2 mm. Sixteen patients (a total of 39 immediate implants in the maxillary anterior and premolar regions) were randomly allocated in a 1:1 ratio to a test group (peri-implant gap filled with injectable β-TCP) or a control group (no grafting). The patient was the unit of analysis. The primary outcome was implant stability, measured by resonance frequency analysis and expressed as the implant stability quotient (ISQ) at baseline, 3 months, and 6 months. The secondary outcome was peri-implant bone density, monitored on standardized digital periapical radiographs (baseline, 3, and 6 months) and quantified at 6 months by a single cone-beam computed tomography (CBCT) scan.
Detailed description
Design: single-center, prospective, parallel-group, randomized controlled trial with a 1:1 allocation ratio. Ethical approval was obtained from the Research Ethics Committee, Faculty of Dentistry, Suez Canal University (approval no. 682/2023), and all procedures were performed in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants. Participants: patients aged 20-50 years requiring extraction of a non-restorable maxillary anterior or premolar root, with a peri-implant jumping gap greater than 2 mm at the implant site. Interventions: after atraumatic extraction and prosthetically driven osteotomy preparation, implants were placed at the crestal level. In the test group the peri-implant gap was filled with injectable β-TCP; in the control group no grafting was performed. Randomization and blinding: the allocation sequence was computer-generated by an investigator not involved in surgery, with concealment by sequentially numbered, opaque, sealed envelopes. Outcome assessors, including the radiographic bone-density readers, were blinded to group allocation. Outcomes: the primary outcome was implant stability (ISQ) at baseline, 3, and 6 months. Secondary outcomes were peri-implant bone density on periapical radiographs (Digora grayscale, 0-255) and on a single 6-month CBCT (gray-value-derived HU-equivalent radiodensity), and implant survival. Analysis used independent-samples t tests for between-group and repeated-measures ANOVA for within-group comparisons (α = 0.05), with the patient as the unit of analysis.
Interventions
DEVICEExperimental: Test: beta-tricalcium phosphate grafting
A β-tricalcium phosphate synthetic bone substitute supplied ready-to-use in a putty carrier (Bonegraft Biomaterials Co., Ltd., Daegu, South Korea), placed into the peri-implant jumping gap (greater th
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 20 to 50 years * Non-restorable maxillary anterior or premolar tooth requiring extraction and immediate implant placement * Peri-implant jumping gap greater than 2 mm at the implant site * Adequate inter-arch space * Good patient compliance
Exclusion criteria
* • Systemic disease affecting healing * Smoking of more than 10 cigarettes per day * Parafunctional habits * Poor oral hygiene * Active periodontal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant stability (implant stability quotient, ISQ) | Baseline (immediately postoperative), 3 months, and 6 months | Implant stability measured by resonance frequency analysis and expressed as the ISQ (unitless, 1-100; higher = more stable). The patient was the unit of analysis; for patients with more than one implant, the mean ISQ of that patient's implants was used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peri-implant bone density on periapical radiographs (Digora grayscale) | Baseline, 3 months, and 6 months | Bone density on standardized digital periapical radiographs (paralleling technique, fixed exposure), analyzed with Digora software as grayscale values (0-255) at the mesial, distal, and apical regions. |
| Peri-implant radiodensity on 6-month cone-beam CT (HU-equivalent) | 6 month | Radiodensity on a single 6-month CBCT along the buccal aspect of each implant at apical, middle, and crestal levels, expressed as gray-value-derived HU-equivalent values; read independently by two blinded radiologists. |
| Implant survival | 6 months | Proportion of implants surviving to the 6-month follow-up, with assessment of infection, implant mobility, and wound dehiscence at each visit. |
Countries
Egypt
Outcome results
None listed