Alveolar Bone Loss, Jaw, Edentulous, Partially, Tooth Loss
Conditions
Keywords
immediate implant placement, customized healing abutment, sulcus former, post-extraction socket, socket classification, molar, implant stability quotient, cone-beam computed tomography, peri-implant soft tissue, emergence profile
Brief summary
Immediate implant placement into a fresh extraction socket shortens overall treatment time and reduces the number of surgical procedures, but the fit between the implant and the socket walls, and the resulting soft-tissue contour, differ substantially between socket types. This study evaluates immediate implant placement in the molar and posterior region combined with an individually fabricated (customized) healing abutment, or sulcus former, that seals the socket and shapes the emergence profile from the day of surgery. Consecutive patients with a non-restorable posterior tooth are treated with flapless atraumatic extraction, immediate implant placement, grafting of the residual gap, and a chairside customized healing abutment fabricated on a titanium temporary abutment. Participants are grouped by the class of the post-extraction socket (A, B or C) according to the interradicular septal bone available for primary stability. Outcomes are preservation of peri-implant soft-tissue volume assessed with an intraoral scanner, preservation of alveolar bone volume assessed on cone-beam computed tomography, implant stability measured by resonance frequency analysis (ISQ) at placement and before loading, and time to definitive loading. Early wound healing on the Landry index, the degree of bone corticalization before loading, implant survival, healing-abutment complications and analgesic requirement are also recorded.
Interventions
Flapless atraumatic extraction with tooth sectioning and root-by-root removal, socket debridement and saline irrigation, followed by immediate placement of a MegaGen AnyRidge implant (MegaGen Implant Co., Daegu, South Korea; diameter 4.0-5.5 mm, length 8.5-11.5 mm) in a subcrestal position at the level of the septal bone. Where insertion torque of at least 35 Ncm and an implant stability quotient of at least 65 are achieved, the residual gap is grafted with equine-derived xenograft granules of 0.25 mm (Maggi Biotechnology, Andezeno, Italy) and a customized healing abutment is fabricated chairside from flowable composite on a titanium temporary abutment (Spider Web technique), hand-tightened and left free of occlusal contact. No barrier membrane is used. Definitive loading is planned at three months.
Sponsors
Plovdiv Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or over * ASA physical status I or II * A non-restorable posterior tooth (premolar or molar) indicated for extraction: clinically unrestorable crown, advanced chronic periodontitis, failed or untreatable endodontic therapy, or vertical root fracture * Residual bone permitting implant placement with adequate primary stability * Able and willing to give written informed consent and to attend the follow-up schedule
Exclusion criteria
* ASA physical status III or higher * Pregnancy or lactation * Uncontrolled diabetes mellitus * Smoking more than 10 cigarettes per day * Drug or alcohol abuse * Current or previous bisphosphonate or other antiresorptive therapy * Head and neck radiotherapy * Immunosuppression * Anticoagulant or antiplatelet therapy where the required pre-operative preparation is declined * Psychiatric conditions preventing compliance with the study procedures * Known titanium allergy * Severe bruxism * Acute infection at the surgical site * Advanced alveolar resorption precluding immediate implant placement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in peri-implant soft-tissue volume | Baseline, 3 months after placement (before loading), and 2 weeks after loading | Volumetric change of the peri-implant soft tissue relative to the pre-extraction baseline, measured in cubic millimetres by superimposition of intraoral scans. |
| Time to definitive loading | Up to 6 months after implant placement | Interval in months from implant placement to definitive prosthetic loading, determined by the pre-loading radiographic assessment and the implant stability quotient. |
| Implant stability quotient (ISQ) | At implant placement and at 3 months after placement (before loading) | Implant stability measured by resonance frequency analysis on the ISQ scale from 1 to 100, where higher values indicate greater stability. Stability before loading is the criterion that determines whether the implant is loaded at three months. |
| Change in alveolar bone volume | Baseline and 3 months after placement (before loading) | Volumetric change of the peri-implant alveolar bone relative to the pre-extraction baseline, measured in cubic millimetres on cone-beam computed tomography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early wound healing | Days 7 and 14 after surgery | Early wound healing graded on the Landry Wound Healing Index from 1 to 5, where higher values indicate better healing. |
| Analgesic requirement | First 5 days after surgery | Number of participants taking the prescribed analgesic (ibuprofen L-arginine 600 mg twice daily as needed) after surgery. |
| Customized healing abutment complications | From surgery to definitive loading, up to 4 months | Number of participants with abutment screw loosening, fracture of the composite healing abutment, or peri-implant infection, each recorded as present or absent. |
| Implant survival | Up to 24 months after implant placement | Proportion of implants in situ and functional at the latest follow-up visit. |
| Peri-implant bone corticalization | 3 months after placement (before loading) | Degree of corticalization of the peri-implant bone, assessed on cone-beam computed tomography using a radiological corticalization index. |
Countries
Bulgaria
Contacts
CONTACTLyubomir Chenchev, DMD, PhD
PRINCIPAL_INVESTIGATORTasho Gavrailov, DMD, PhD
Medical University of Plovdiv
Outcome results
None listed