Not Yet RecruitingNot Applicable

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

Spain75 participantsStarted 2025-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

Dimensional changes in the peri-implamt soft tissue

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

Trial details

NCT IDNCT07031232

SponsorUniversity of Valencia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-31