Immediate Molar Implants With Customized Healing Abutments in Different Post-Extraction Socket Classes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPlovdiv Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
ASA physical status III or higher
Pregnancy or lactation
Uncontrolled diabetes mellitus
Smoking more than 10 cigarettes per day
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Immediate implant placement with customized healing abutment
Procedure/SurgeryFlapless 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Socket class A1 intervention
Group B: Socket class B1 intervention
Group C: Socket class C1 intervention
Trial outcomes
Primary outcomes
1
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 loading2
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 placement3
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)4
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)Secondary outcomes
1
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 surgery2
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 surgery3
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 months4
Implant survival
Proportion of implants in situ and functional at the latest follow-up visit.
Time frame
Up to 24 months after implant placementSponsors and contacts
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Source ClinicalTrials.gov