Tooth LossIMPLA-CHANCT07801573
Immediate Molar Implants With Customized Healing Abutments in Different Post-Extraction Socket Classes
An observational study of Tooth Loss and Alveolar Bone Loss, run by Plovdiv Medical University at 1 site in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Loss, Alveolar Bone Loss, Jaw, Edentulous, Partially
- What is being tested?
- Immediate implant placement with customized healing abutment
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Apr 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bulgaria1 site, 1 recruiting
- Recruiting
Department of Dental Implantology, Faculty of Dental Medicine, Medical University - Plovdiv
Plovdiv, 4000
Lyubomir Chenchev, DMD, PhD, +359 887 102 516, lyubomir.chenchev@mu-plovdiv.bg
About this study
Official 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
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
- Being tested
- Immediate implant placement with customized healing abutment
- 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
- Medical subject headings
- Tooth Loss, Alveolar Bone Loss, Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant placement with customized healing abutmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Immediate implant placement with customized healing abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months after placement (before loading)
Secondary outcomes (5)
Early wound healing
Early wound healing graded on the Landry Wound Healing Index from 1 to 5, where higher values indicate better healing.
Measured: 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.
Measured: 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.
Measured: From surgery to definitive loading, up to 4 months
Implant survival
Proportion of implants in situ and functional at the latest follow-up visit.
Measured: 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.
Measured: 3 months after placement (before loading)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Apr 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Plovdiv Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tasho Gavrailov, DMD, PhD, Principal investigator, Medical University of Plovdiv
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801573
- Sponsor's protocol ID
- NO-18/2025
- Other IDs
- R-KNE-55/10.11.2025
- Acronym
- IMPLA-CHA
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07801573
- Acronym / sponsor ID
- IMPLA-CHA / NO-18/2025
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Plovdiv Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Socket class A | – | Procedure: Immediate implant placement with customized healing abutmentPosterior 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. |
| Socket class B | – | Procedure: Immediate implant placement with customized healing abutmentPosterior 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. |
| Socket class C | – | Procedure: Immediate implant placement with customized healing abutmentPosterior 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- ASA physical status III or higher
- Pregnancy or lactation
- Uncontrolled diabetes mellitus
- Smoking more than 10 cigarettes per day
- Drug or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate implant placement with customized healing abutmentFlapless 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. | Procedure or surgery | Socket class A, Socket class B, Socket class C |
Primary outcome
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.
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.
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.
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.
5 secondary outcomes
Early wound healing
Time frame: Days 7 and 14 after surgery
Analgesic requirement
Time frame: First 5 days after surgery
Customized healing abutment complications
Time frame: From surgery to definitive loading, up to 4 months
Implant survival
Time frame: Up to 24 months after implant placement
Peri-implant bone corticalization
Time frame: 3 months after placement (before loading)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tasho Gavrailov, DMD, PhD principal investigator
Medical University of Plovdiv
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Loss and Alveolar Bone Loss, run by Plovdiv Medical University at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lyubomir Chenchev, DMD, PhD (+359 887 102 516, lyubomir.chenchev@mu-plovdiv.bg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peri-implant soft-tissue volume (time frame: Baseline, 3 months after placement (before loading), and 2 weeks after loading). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.