An observational study in Tooth Loss, Alveolar Bone Loss and Jaw, Edentulous, Partially, sponsored by Plovdiv Medical University. Recruiting at 1 site in Bulgaria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Plovdiv Medical University · Observational
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.
Consecutive adult patients attending the Department of Dental Implantology, Faculty of Dental Medicine, Medical University - Plovdiv, with a non-restorable posterior (premolar or molar) tooth indicated for extraction and suitable for immediate implant placement.
Exclusion Criteria:
Posterior extraction socket in which the interradicular septal bone is sufficient to house the implant, giving circumferential bone contact along its coronal part. Because a molar socket is frequently 10 mm or more across, a residual void commonly remains around the implant within the socket. Participants receive immediate implant placement with a chairside customized healing abutment.
Procedure: Immediate implant placement with customized healing abutment
Posterior extraction socket in which the septal bone is sufficient to stabilise the implant but not to house it, so that part of the implant surface faces the socket rather than bone. Participants receive immediate implant placement with a chairside customized healing abutment.
Procedure: Immediate implant placement with customized healing abutment
Posterior extraction socket with little or no septal bone, so that primary stability must be obtained from the peripheral socket walls and/or the bone apical to the socket. Participants receive immediate implant placement with a chairside customized healing abutment.
Procedure: Immediate implant placement with customized healing abutment
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.
Change in peri-implant soft-tissue volume
Volumetric change of the peri-implant soft tissue relative to the pre-extraction baseline, measured in cubic millimetres by superimposition of intraoral scans.
Time frame: Baseline, 3 months after placement (before loading), and 2 weeks after loading
Time to definitive loading
Interval in months from implant placement to definitive prosthetic loading, determined by the pre-loading radiographic assessment and the implant stability quotient.
Time frame: Up to 6 months after implant placement
Implant stability quotient (ISQ)
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.
Time frame: At implant placement and at 3 months after placement (before loading)
Change in alveolar bone volume
Volumetric change of the peri-implant alveolar bone relative to the pre-extraction baseline, measured in cubic millimetres on cone-beam computed tomography.
Time frame: Baseline and 3 months after placement (before loading)
Early wound healing
Early wound healing graded on the Landry Wound Healing Index from 1 to 5, where higher values indicate better healing.
Time frame: Days 7 and 14 after surgery
Analgesic requirement
Number of participants taking the prescribed analgesic (ibuprofen L-arginine 600 mg twice daily as needed) after surgery.
Time frame: First 5 days after surgery
Customized healing abutment complications
Number of participants with abutment screw loosening, fracture of the composite healing abutment, or peri-implant infection, each recorded as present or absent.
Time frame: From surgery to definitive loading, up to 4 months
Implant survival
Proportion of implants in situ and functional at the latest follow-up visit.
Time frame: Up to 24 months after implant placement
Peri-implant bone corticalization
Degree of corticalization of the peri-implant bone, assessed on cone-beam computed tomography using a radiological corticalization index.
Time frame: 3 months after placement (before loading)
Plan to share: No — Individual participant data will not be made publicly available. De-identified data supporting the published analyses are available from the corresponding author on reasonable request.
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Plovdiv Medical University