Tissue Preservation in Immediate 1C Implants Using an Anatomical Prefabricated Healing Abutment
Aharct
1 other identifier
interventional
30
1 country
2
Brief Summary
The goal of this clinical trial is to evaluate whether an anatomical prefabricated healing abutment (AHA) improves tissue preservation and clinical outcomes following immediate implant placement after tooth extraction in adults. Although immediate implant placement is a well-established treatment for replacing missing teeth, healing can result in changes to the surrounding bone and soft tissues that may affect the esthetic appearance, function, and long-term stability of the implant-supported restoration. This study will compare an anatomical healing abutment, designed to mimic the natural tooth emergence profile and support peri-implant tissues during healing, with a conventional healing abutment. The primary objectives are to determine whether the AHA better preserves soft tissue contours and alveolar bone, improves implant positioning accuracy and tissue stability during healing, and differs from a conventional healing abutment in complications or adverse events. Eligible participants will be adults requiring extraction of a hopeless tooth in the posterior maxilla or mandible who are suitable candidates for immediate implant placement. Following tooth extraction and implant placement, participants will receive either an anatomical prefabricated healing abutment or a conventional healing abutment and will return for scheduled follow-up visits over approximately 12 months to assess healing, implant stability, and changes in the surrounding hard and soft tissues. Researchers will collect clinical measurements, digital intraoral scans, photographs, and radiographic images throughout the study. Additional research imaging will be used to generate three-dimensional models to measure tissue volume changes and implant position accuracy. Specialized software will compare changes between the two groups over time. Safety will be evaluated by monitoring participants for complications, discomfort, inflammation, implant-related problems, and other adverse events throughout follow-up. All procedures will be performed by trained dental professionals using established clinical protocols. The results may improve understanding of how healing abutment design influences tissue preservation after immediate implant placement and help optimize future implant therapy by supporting better functional, esthetic, and long-term outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2026
CompletedFirst Posted
Study publicly available on registry
July 27, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
Study Completion
Last participant's last visit for all outcomes
September 1, 2028
July 27, 2026
July 1, 2026
1.5 years
July 14, 2026
July 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Three-dimensional (3D) peri-implant soft tissue volumetric changes within the region of interest (ROI)
To assess soft tissue three-dimensional (3D) volumetric changes by calculating the percentage variation in cubic millimeters (% mm³) within defined regions of interest (ROI), using superimposed consecutive digital surface models (intraoral scans) obtained at pre-extraction (T1), impression (T3), baseline/prosthesis delivery (T4), 6 months (T5), and 12 months (T6), at the Geomagic® metrology software. This endpoint will assess the ability of the scannable anatomical healing abutment to preserve peri-implant soft tissue contours following immediate implant placement. Longitudinal changes will be analyzed using mixed-effects models to evaluate the interaction between treatment group and time.
From enrollment to the end of treatment at 12 months follow-up
Secondary Outcomes (17)
Mid-facial mucosal margin (MM) level
From enrollment to the 12-months follow-up
Keratinized mucosa width (KMW)
From enrollment to 12-months follow-up
Pink Esthetic Score (PES)
From prosthesis delivery to 12-months follow-up
Implant position accuracy
From implant planning to immediate post-implant placement
3D hard tissue change (3DHT)
From implant placement to 12-months follow-up
- +12 more secondary outcomes
Study Arms (2)
AHA Group
EXPERIMENTALParticipants assigned to the experimental group will receive a prefabricated anatomical healing abutment (AHA) following immediate implant placement after tooth extraction. The AHA is a healing component designed to better reproduce the natural emergence profile of the extracted tooth and provide anatomical support to the surrounding peri-implant soft tissues during the healing period. After placement of the dental implant, the anatomical prefabricated healing abutment will be connected to the implant and maintained throughout the initial healing phase until the definitive implant-supported restoration is provided according to standard clinical procedures. The intervention is intended to evaluate whether maintaining a more natural tissue contour during healing improves preservation of peri-implant soft tissue volume and stability compared with a conventional healing abutment. Participants will undergo routine clinical follow-up evaluations to measure changes in the soft tissues.
Conventional Healing Abutment Group
ACTIVE COMPARATORParticipants assigned to the control group will receive a conventional healing abutment following immediate implant placement after tooth extraction. The conventional healing abutment represents the standard approach commonly used during the implant healing phase and is designed to allow the surrounding soft tissues to heal and form an appropriate contour around the implant site before placement of the definitive implant-supported restoration. Following implant placement, the conventional healing abutment will be connected to the implant and maintained during the initial healing period according to standard clinical protocols. Participants will undergo the same follow-up schedule and evaluations as the experimental group. Data collected during the 12-month follow-up period will be used to compare changes in peri-implant soft tissue contour, tissue volume preservation, bone remodeling, implant stability, and other clinical outcomes between the control and test groups.
Interventions
The anatomical prefabricated healing abutment (AHA) is a dental implant healing component specifically designed to reproduce the natural emergence profile of the extracted tooth and provide anatomical support to the peri-implant soft tissues during the healing phase following immediate implant placement. Unlike conventional healing abutments, which typically have a standardized cylindrical shape, the AHA is designed with an anatomical contour intended to better maintain the 3D shape and volume of the soft tissues surrounding the implant. The intervention consists of placement of the AHA immediately after implant insertion and its use throughout the healing period until delivery of the definitive implant-supported restoration. The effectiveness of the AHA will be evaluated by comparing three-dimensional soft tissue volume changes, tissue contour preservation, bone remodeling, implant positioning outcomes, and clinical parameters with those observed using a conventional healing abutment.
The conventional healing abutment is a standard prefabricated healing component used during the healing phase following dental implant placement. Unlike the anatomical prefabricated healing abutment evaluated in the experimental group, it has a standardized, generally cylindrical contour and is not specifically designed to replicate the natural emergence profile of the extracted tooth. After implant placement, it is connected to the implant to allow the surrounding soft tissues to heal and establish an appropriate peri-implant tissue contour before placement of the definitive implant-supported restoration. The intervention consists of the placement and maintenance of the conventional healing abutment during the healing period according to standard clinical practice. Outcomes will be compared with the anatomical prefabricated healing abutment group to evaluate differences in soft tissue volume preservation, tissue contour changes, bone remodeling, and other clinical parameters.
Eligibility Criteria
You may qualify if:
- Willing to sign an IRB-approved informed consent and HIPAA authorization form prior to participation.
- Between the ages of 20 and 75 years old.
- ASA Classification I and II.
- Hopeless maxillary or mandibular posterior teeth, eligible for immediate implantation, and with intact/successfully restored adjacent teeth.
- Willing to perform tasks associated with the study and to attend all study visits.
You may not qualify if:
- HbA1c \>6.5%) as per a chairside test (Siemens Bayer DCA 2000+);
- smoker (any status);
- immunodeficiency;
- history of head and neck radiotherapy;
- intake of bone anti-resorptive drugs;
- cysts or tumors in the area;
- self-reported pregnancy;
- poor oral hygiene;
- active periodontal disease;
- acute endodontic infection and pus discharge on the site itself and adjacent areas;
- lack of mutually protected occlusion;
- insufficient inter-occlusal clearance (\<15 mm);
- sites with an existing midfacial mucogingival recession/deficiency (scar tissue);
- sites with a high-scalloped, thin biotype.
- Sites with an intact or minimally damaged facial bone plate measuring greater than 1 mm in thickness;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Illinois at Chicagolead
- Indiana Universitycollaborator
- Institut Straumann AGcollaborator
- ITI International Team for Implantology, Switzerlandcollaborator
Study Sites (2)
University of Illinois Chicago College of Dentistry
Chicago, Illinois, 60612, United States
Indiana University School of Dentistry
Indianapolis, Indiana, 46202, United States
Related Publications (14)
Lambert, F., & Hamilton, A. (2023). Immediate Implant Placement and Loading - Single or Multiple Teeth Requiring Replacement (ITI Treatment Guide Series, Vol. 14). Quintessence Publishing.
BACKGROUNDKuza CM, Matsushima K, Mack WJ, Pham C, Hourany T, Lee J, Tran TD, Dudaryk R, Mulder MB, Escanelle MA, Ogunnaike B, Ahmed MI, Luo X, Eastman A, Imran JB, Melikman E, Minhajuddin A, Feeler A, Urman RD, Salim A, Spencer D, Gabriel V, Ramakrishnan D, Nahmias JT. The role of the American Society of anesthesiologists physical status classification in predicting trauma mortality and outcomes. Am J Surg. 2019 Dec;218(6):1143-1151. doi: 10.1016/j.amjsurg.2019.09.019. Epub 2019 Sep 24.
PMID: 31575418BACKGROUNDde Grandmont P, Feine JS, Tache R, Boudrias P, Donohue WB, Tanguay R, Lund JP. Within-subject comparisons of implant-supported mandibular prostheses: psychometric evaluation. J Dent Res. 1994 May;73(5):1096-104. doi: 10.1177/00220345940730051201.
PMID: 8006237BACKGROUNDSlade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
PMID: 9332805BACKGROUNDTonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Clin Periodontol. 2018 Jun;45 Suppl 20:S149-S161. doi: 10.1111/jcpe.12945.
PMID: 29926495BACKGROUNDAcademy of Osseointegration. 2010 Guidelines of the Academy of Osseointegration for the provision of dental implants and associated patient care. Int J Oral Maxillofac Implants. 2010 May-Jun;25(3):620-7. No abstract available.
PMID: 20653117BACKGROUNDLi Y, Qiao SC, Gu YX, Zhang XM, Shi JY, Lai HC. A novel semiautomatic segmentation protocol to evaluate guided bone regeneration outcomes: A pilot randomized, controlled clinical trial. Clin Oral Implants Res. 2019 Apr;30(4):344-352. doi: 10.1111/clr.13420. Epub 2019 Mar 27.
PMID: 30854705BACKGROUNDFurhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
PMID: 16307569BACKGROUNDGolmayo P, Barallat L, Losada M, Valles C, Nart J, Pascual-La Rocca A. Keratinized tissue gain after free gingival graft augmentation procedures around teeth and dental implants: A prospective observational study. J Clin Periodontol. 2021 Feb;48(2):302-314. doi: 10.1111/jcpe.13394. Epub 2020 Nov 18.
PMID: 33098670BACKGROUNDFernandes D, Nunes S, Lopez-Castro G, Marques T, Montero J, Borges T. Effect of customized healing abutments on the peri-implant linear and volumetric tissue changes at maxillary immediate implant sites: A 1-year prospective randomized clinical trial. Clin Implant Dent Relat Res. 2021 Oct;23(5):745-757. doi: 10.1111/cid.13044. Epub 2021 Aug 22.
PMID: 34423560BACKGROUNDFinelle G, Popelut A, Knafo B, Martin IS. Sealing Socket Abutments (SSAs) in Molar Immediate Implants with a Digitalized CAD/CAM Protocol: Soft Tissue Contour Changes and Radiographic Outcomes After 2 Years. Int J Periodontics Restorative Dent. 2021 Mar-Apr;41(2):235-244. doi: 10.11607/prd.4579.
PMID: 33819330BACKGROUNDMenchini-Fabris GB, Crespi R, Toti P, Crespi G, Rubino L, Covani U. A 3-year retrospective study of fresh socket implants: CAD/CAM customized healing abutment vs cover screws. Int J Comput Dent. 2020;23(2):109-117.
PMID: 32555764BACKGROUNDRavinder R, Dubey P, Raj S, Mishra P, Rajput A. Immediate implant placement in posterior maxilla: a prospective clinical study. J Osseointegr. 2021;13(4):185-90.
BACKGROUNDRagucci GM, Elnayef B, Criado-Camara E, Del Amo FS, Hernandez-Alfaro F. Immediate implant placement in molar extraction sockets: a systematic review and meta-analysis. Int J Implant Dent. 2020 Oct 13;6(1):40. doi: 10.1186/s40729-020-00235-5.
PMID: 32770283BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luis Mezzomo, PhD
University of Illinois at Chicago
- PRINCIPAL INVESTIGATOR
Waldemar Polido, PhD
Indiana University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Surgeon
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
July 14, 2026
First Posted
July 27, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
July 27, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Individual Participant Data (IPD) and supporting documentation will become available following publication of the primary study results or within 12 months after completion of the study, whichever occurs first. The data will remain available for up to 5 years after publication of the primary results. Start Date for IPD Sharing: December 2029 (or within 12 months after study completion/publication) End Date for IPD Sharing: December 2034
- Access Criteria
- Access to de-identified individual participant data (IPD) and supporting documents will be granted to qualified researchers for scientifically sound research that is consistent with the objectives of the original study. Investigators requesting access must submit a written research proposal describing the study objectives, planned analyses, and statistical methods. Requests will be reviewed by the study investigators to assess scientific merit, ethical considerations, participant confidentiality, and feasibility. Approved investigators may be required to sign a Data Use Agreement (DUA) before receiving access. Data will be provided in a de-identified electronic format through secure institutional file transfer. Supporting documents, including the study protocol, statistical analysis plan, informed consent form, clinical study report, and analytic code, will be made available under the same conditions.
De-identified individual participant data (IPD) underlying the published study results will be shared. The dataset will include participant demographics, baseline clinical characteristics, treatment allocation, implant-related variables, clinical measurements, three-dimensional digital intraoral scan measurements of peri-implant soft tissue contour and volume, radiographic measurements of hard tissue changes, implant position accuracy, implant stability, adverse events, and follow-up data. All direct identifiers will be removed before data sharing, and each participant will be identified only by a unique study code. No information that could reasonably identify individual participants will be included.