Peri-implant Tissues Changes for Different Abutment Shapes and Heights
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol.
- Who it may be relevant to
- Registry conditions: Dental Implant-Abutment Designs, Marginal Bone Loss in Different Abutment Designs, Soft Tissue Management in Subcrestal Dental Implants. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Influence of Supracrestal Soft Tissue on Peri-implant Bone Changes for Different Abutment Shapes and Heights: A Four-Arm Randomized Clinical Trial
Overview
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.
Interventions
- 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" p
Primary outcome measures
- Changes in peri-implant marginal bone level (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.]
Secondary outcome measures (3)
- Peri-implant probing depth (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) [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 [Time frame: From the time of surgery through the end of the 12-month follow-up period after definitive prosthesis placement.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Universitat de València — Valencia
Identifiers
NCT: NCT07509281 · UV-INV-ETICA-3792382