RecruitingNot ApplicableNCT07509281

Peri-implant Tissues Changes for Different Abutment Shapes and Heights

Influence of Supracrestal Soft Tissue on Peri-implant Bone Changes for Different Abutment Shapes and Heights: A Four-Arm Randomized Clinical Trial


Sponsor

University of Valencia

Enrollment

180 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this randomized clinical trial is to investigate the influence of supracrestal soft tissue on abutments of different heights (2-mm vs. 3-mm) and shapes (cylindrical abutment vs. concave abutment) on changes in the marginal bone level (bone loss and bone remodeling) in healthy, partially edentulous volunteer patients undergoing implant-supported rehabilitation. The main questions it aims to answer are: * Is there any difference in marginal bone loss for different abutment shapes and heights? * Do the shape and height of the abutment affect implant success? All participants will receive bone-level dental implants placed approximately 2-mm below the bone crest, each receiving a different type of abutment and researchers will see whether the shape and height of the abutment influence the success of the implant, periodontal probing depth (PPD), and bleeding on probing (BoP) comparing four groups of patients: 1. 2-mm high abutments with cylindrical shape. 2. 2-mm high abutments with concave shape. 3. 3-mm high abutments with cylindrical shape. 4. 3-mm high abutments with concave shape. Clinical and radiographic assessments will be performed at abutment placement, at definitive prosthesis placement, and at 1, 3, 6, and 12 months after loading to measure marginal bone loss and peri-implant parameters.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • Adults aged 18 years or older.
  • Posterior edentulism (premolars/molars).
  • Good general and oral health, with controlled plaque and bleeding indices.
  • Sufficient bone height and width for implant placement without the need for bone regeneration procedures. Patients who require indirect sinus lift procedure simultaneously with implant placement may be included in the study.
  • Presence of at least 2 mm of keratinized mucosa around the dental implant.
  • Stable occlusion and healthy periodontium.
  • Insertion torque ≥ 35 Ncm at the time of implant placement.
  • Willingness to comply with study protocol and attend scheduled follow-up visits.

Exclusion Criteria4

  • Presence of medical conditions that contraindicate implant surgery, such as heavy smoking (>10 cigarettes per day), severe bruxism, pregnancy or breastfeeding, bisphosphonate therapy, and patients undergoing chemotherapy or radiotherapy in the head and/or neck area.
  • Active periodontal disease or peri-implant infection.
  • Uncooperative patients or patients unable to complete follow- up.
  • Implant failures.

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Interventions

PROCEDUREBone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol

Participants will receive bone-level dental implants placed approximately 2 mm below the bone crest in a healed posterior site of the maxilla or mandible. The implants will be placed using biological drilling protocol and inserted with a final torque of at least 35 Ncm following the manufacturer's instructions . A transmucosal abutment according to the applicable randomization will be connected at the time of surgery with a final torque of at least 30 Ncm, following the "one abutment-one time" philosophy in order to avoid any changes in hard and soft peri-implant tissues.


Locations(1)

Universitat de València

Valencia, Valencia, Spain

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NCT07509281