Immediate Molar Implants With Customized Healing Abutments in Different Post-Extraction Socket Classes

NCT07801573 | Recruiting

• 2 other identifiers: NO-18/2025R-KNE-55/10.11.2025
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Loss; Alveolar Bone Loss; Jaw, Edentulous, Partially

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline and 3 months after placement (before loading)

Secondary Outcomes (5)

• Early wound healing

  Days 7 and 14 after surgery

• Analgesic requirement

  First 5 days after surgery

• Customized healing abutment complications

  From surgery to definitive loading, up to 4 months

• Implant survival

  Up to 24 months after implant placement

• Peri-implant bone corticalization

  3 months after placement (before loading)

Study Arms (3)

Socket class A

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

Socket class B

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

Socket class C

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

Interventions

Immediate implant placement with customized healing abutment PROCEDURE

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.

Socket class A; Socket class B; Socket class C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Plovdiv Medical University: lead

Study Sites (1)

Department of Dental Implantology, Faculty of Dental Medicine, Medical University - Plovdiv

Plovdiv, 4000, Bulgaria

RECRUITING

MeSH Terms

Conditions

Tooth Loss; Alveolar Bone Loss; Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Jaw, Edentulous; Jaw Diseases; Mouth, Edentulous

Study Officials

• Tasho Gavrailov, DMD, PhD

  Medical University of Plovdiv

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lyubomir Chenchev, DMD, PhD

CONTACT

+359 887 102 516; lyubomir.chenchev@mu-plovdiv.bg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)