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NCT Number: NCT07801573

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

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.

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Key information

Conditions

Tooth Loss Alveolar Bone Loss Bone Diseases Bone Resorption Jaw Diseases Jaw, Edentulous Jaw, Edentulous, Partially Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Plovdiv, 4000, Bulgaria

Location status: Recruiting

Location contact

Lyubomir Chenchev, DMD, PhD

CONTACT

[email protected]

+359 887 102 516

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in peri-implant soft-tissue volume

    Time frame: 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.

  2. Time to definitive loading

    Time frame: 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.

  3. Implant stability quotient (ISQ)

    Time frame: 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.

  4. Change in alveolar bone volume

    Time frame: 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 outcomes

  1. Early wound healing

    Time frame: 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.

  2. Analgesic requirement

    Time frame: First 5 days after surgery

    Number of participants taking the prescribed analgesic (ibuprofen L-arginine 600 mg twice daily as needed) after surgery.

  3. Customized healing abutment complications

    Time frame: 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.

  4. Implant survival

    Time frame: Up to 24 months after implant placement

    Proportion of implants in situ and functional at the latest follow-up visit.

  5. Peri-implant bone corticalization

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lyubomir Chenchev, DMD, PhD

CONTACT

[email protected]

+359 887 102 516

Sponsors and collaborators

Lead sponsor

Plovdiv Medical University

Other

Registry information

Official study title

Evaluation of the Success of Immediate Implants in the Molar Region Using Individually Fabricated Healing Abutments (Sulcus Formers) in Different Classes of Post-Extraction Sockets: A Prospective Cohort Study

Acronym: IMPLA-CHA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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