An interventional study of Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol in Dental Implant-Abutment Designs, Marginal Bone Loss in Different Abutment Designs and Soft Tissue Management in Subcrestal Dental Implants, sponsored by University of Valencia. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by University of Valencia · Not applicable, Interventional, and Treatment
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:
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:
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.
University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.
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Exclusion Criteria:
Participants in this group will receive a 2-mm high abutment with cylindrical shape 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
Participants in this group will receive a 2-mm high abutment with concave shape 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
Participants in this group will receive a 3-mm high abutment with cylindrical shape 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
Participants in this group will receive a 3-mm high abutment with concave shape 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
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.
Changes in peri-implant marginal bone level (mm)
Parallelized periapical radiographs will be obtained and a calibrated digital tool will be used to determine the vertical distance from the implant-abutment junction to the most coronal bone-to-implant contact on the mesial and distal sides. Unit of measure: Milimeters (mm)
Time frame: From abutment placement (baseline time [TB]), 3 months post-op (prosthetic loading) (T0), and at months 1 (T1), 3 (T3), 6 (T6), and 12 (T12) after definitive prosthesis placement.
Peri-implant probing depth (mm)
Peri-implant soft tissue condition will be assessed by recording PPD using a periodontal probe at six surfaces per implant (mesiobuccal, midbuccal, distobuccal, and the corresponding lingual/palatal sites) to calculate the mean of every implant. Unit of measure: Milimeters (mm)
Time frame: 3 months post-op (prosthetic loading) (T0), and at months 1 (T1), 3 (T3), 6 (T6), and 12 (T12) after definitive prosthesis placement.
Bleeding on probing (presence/absence)
Bleeding on probing will be measured by gently passing a periodontal probe (using \~20-25g of force) to the base of the sulcus/pocket of the prosthesis at six surfaces per implant (mesiobuccal, midbuccal, distobuccal, and the corresponding lingual/palatal sites), then waiting 30 seconds to observe bleeding. It will be recorded as a dichotomous score (yes/no). Unit of measure: Percentage of sites showing bleeding per implant.
Time frame: 3 months post-op (prosthetic loading) (T0), and at months 1 (T1), 3 (T3), 6 (T6), and 12 (T12) after definitive prosthesis placement.
Implant success
Assessment of the implants will follow the criteria outlined by Misch et al. (2008) categorizing them into success (optimal health), satisfactory survival, compromised survival, or failure.
Time frame: From the time of surgery through the end of the 12-month follow-up period after definitive prosthesis placement.
General variables
Patient age and sex, smoking habit (no smoking or ≤10 cigarettes/day), brushing habit (0, 1-2 or 3 times/day), edentulism (interdental or free end), phenotype (thin or thick), antagonist (natural teeth, bridge on teeth, implant rehabilitation or removable rehabilitation), cause of dental loss (caries, periodontitis or fracture), arch, quadrant, and soft tissue thickness (in mm) will be collected.
Time frame: At enrollment time.
Plan to share: Undecided — The plan to share individual participant data (IPD) has not yet been determined.
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