Comparative Clinical Study of Conventional vs Customized Healing Abutments in Dental Implantology

NCT07031232 | Not Yet Recruiting DMC

• 1 other identifier: UV-INV_ETICA-3494808
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study evaluates how different healing abutment designs influence the healing and preservation of the soft tissues surrounding dental implants. Healing abutments are temporary components placed on implants during the healing phase to help shape the gum tissue before placing the final crown or prosthesis. The way these components interact with the gum tissue may affect the long-term stability, volume, and aesthetics of the peri-implant soft tissue. All participating patients will receive bone-level dental implants placed approximately 2 mm below the bone crest (subcrestal position). The study will include three groups of patients, each receiving a different type of healing abutment: Group 1 (Control): will receive a standard cylindrical healing abutment. Group 2: will receive a wide healing abutment with an enlarged base to support more soft tissue volume. Group 3: will receive a customized healing abutment designed using digital intraoral scanning and CAD/CAM technology, intended to replicate the final prosthetic emergence profile. The goal is to evaluate which type of healing abutment helps to preserve the natural volume and shape of the gum tissue most effectively during the healing period. The primary focus will be on measuring changes in soft tissue volume and thickness around the implants over time. Participants will undergo digital intraoral scans before surgery and at 3, 6, and 12 months after implant placement. These scans will be used to assess how the gum tissue changes in response to each type of abutment using 3D analysis and software-based measurements. This study is important because maintaining healthy and stable soft tissue around dental implants plays a crucial role in achieving successful, long-lasting, and aesthetically pleasing results. By understanding how healing abutment design affects tissue healing, clinicians may be better equipped to select the most appropriate healing protocol for each patient.

Conditions

Peri-implant Soft Tissue Healing; Soft Tissue Management in Subcrestal Dental Implants; Healing Abutment Influence on Gingival Volume

Outcome Measures

Primary Outcomes (1)

• Dimensional changes in the peri-implamt soft tissue

  Soft tissue changes will be assessed using digital intraoral scans obtained at baseline, immediately after surgery, and at 3, 6, and 12 months. STL files will be superimposed using 3D analysis software based on stable anatomical landmarks. Volumetric and linear changes will be calculated within defined buccal and interproximal regions of interest (ROIs). Parameters include soft tissue volume (mm³), thickness (mm), and gingival margin displacement. Color-coded deviation maps will visualize contour stability. All measurements will be performed in duplicate by calibrated, blinded evaluators. This method offers accurate, reproducible, and non-invasive assessment of peri-implant soft tissue dynamics.

  Preoperative, the day of the intervention and a follow up until 12 months

Study Arms (3)

Standard Healing Abutment Group

EXPERIMENTAL

Participants in this group will receive a conventional, prefabricated cylindrical titanium healing abutment placed immediately after implant surgery. The abutment will remain in place throughout the healing period, following a one abutment-one time protocol.

Procedure: Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol Using Healing Abutments

Wide Healing Abutment Group

EXPERIMENTAL

Participants in this group will receive a prefabricated wide healing abutment with an increased diameter designed to provide broader mucosal support. The abutment will be placed immediately after surgery and will not be removed during healing.

Procedure: Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol Using Healing Abutments

Customized Healing Abutment Group

EXPERIMENTAL

Participants in this group will receive a customized healing abutment fabricated with composite using a preform-phantoma. The abutment will replicate the desired emergence profile of the final prosthesis. It will be placed immediately after surgery and left in place during the healing phase.

Procedure: Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol Using Healing Abutments

Interventions

Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol Using Healing Abutments PROCEDURE

All participants will receive a single bone-level dental implant placed in a healed posterior site of the maxilla or mandible. The implants will be placed using a biological drilling protocol and inserted with a final torque of at least 30 Ncm. A 2 mm transmucosal one-piece abutment (mono-block) will be connected at the time of surgery, following a one abutment-one time philosophy. Each patient will receive a healing abutment immediately after implant placement according to their allocated study group (standard, wide, or customized). The assigned healing abutment will not be removed throughout the healing period. All procedures will be carried out under local anesthesia in a standard clinical setting.

Customized Healing Abutment Group; Standard Healing Abutment Group; Wide Healing Abutment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• Patients requiring a single dental implant in a healed posterior site (maxilla or mandible).
• Presence of at least 2 mm of keratinized mucosa at the implant site.
• Healed alveolar ridge with sufficient bone volume for implant placement without need for guided bone regeneration.
• Good general and oral health, with controlled plaque and bleeding indices.
• Insertion torque ≥ 30 Ncm at the time of implant placement.
• Willingness to comply with study protocol and attend scheduled follow-up visits.
• Signed informed consent.

You may not qualify if:

• Smoking more than 10 cigarettes per day.
• Uncontrolled systemic diseases (e.g., uncontrolled diabetes, immunosuppression).
• History of head or neck radiation therapy.
• Current or recent use of bisphosphonates.
• Active periodontal disease or peri-implant infection.
• Severe parafunctional habits (e.g., bruxism, clenching).
• Pregnant or breastfeeding women.
• Previous implant failure at the intended site.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Universitat de València

Valencia, Valencia, 46010, Spain

Location

Related Publications (4)

• Perez A, Caiazzo A, Valente NA, Toti P, Alfonsi F, Barone A. Standard vs customized healing abutments with simultaneous bone grafting for tissue changes around immediate implants. 1-year outcomes from a randomized clinical trial. Clin Implant Dent Relat Res. 2020 Feb;22(1):42-53. doi: 10.1111/cid.12871. Epub 2019 Dec 3.

  PMID: 31797548 BACKGROUND

• Chokaree P, Poovarodom P, Chaijareenont P, Rungsiyakull P. Effect of Customized and Prefabricated Healing Abutments on Peri-Implant Soft Tissue and Bone in Immediate Implant Sites: A Randomized Controlled Trial. J Clin Med. 2024 Feb 2;13(3):886. doi: 10.3390/jcm13030886.

  PMID: 38337580 BACKGROUND

• Puisys A, Auzbikaviciute V, Vindasiute-Narbute E, Pranskunas M, Razukevicus D, Linkevicius T. Immediate implant placement vs. early implant treatment in the esthetic area. A 1-year randomized clinical trial. Clin Oral Implants Res. 2022 Jun;33(6):634-655. doi: 10.1111/clr.13924. Epub 2022 Apr 7.

  PMID: 35318752 BACKGROUND

• Akin R, Chapple AG. Clinical Advantages of Immediate Posterior Implants With Custom Healing Abutments: Up to 8-Year Follow-Up of 115 Cases. J Oral Maxillofac Surg. 2022 Dec;80(12):1952-1965. doi: 10.1016/j.joms.2022.08.014. Epub 2022 Aug 30.

  PMID: 36155739 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor and Research Director in Oral Surgery and Implantology, Universitat de València

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2029
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)