Peri-implant Tissues Changes for Different Abutment Shapes and Heights

NCT07509281 | Recruiting

• 1 other identifier: UV-INV-ETICA-3792382
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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:
• 2-mm high abutments with cylindrical shape.
• 2-mm high abutments with concave shape.
• 3-mm high abutments with cylindrical shape.
• 3-mm high abutments with concave shape.

Conditions

Soft Tissue Management in Subcrestal Dental Implants; Dental Implant-Abutment Designs; Marginal Bone Loss in Different Abutment Designs

Keywords

dental implant; implant abutment; marginal bone loss; prostheses abutment width; prostheses abutment height

Outcome Measures

Primary Outcomes (1)

• 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)

  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 Outcomes (3)

• Peri-implant probing depth (mm)

  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)

  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

  From the time of surgery through the end of the 12-month follow-up period after definitive prosthesis placement.

Other Outcomes (1)

• General variables

  At enrollment time.

Study Arms (4)

2-mm high abutment with cylindrical shape

EXPERIMENTAL

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

2-mm high abutment with concave shape

EXPERIMENTAL

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

3-mm high abutment with cylindrical shape

EXPERIMENTAL

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

3-mm high abutment with concave shape

EXPERIMENTAL

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

Interventions

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

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.

2-mm high abutment with concave shape; 2-mm high abutment with cylindrical shape; 3-mm high abutment with concave shape; 3-mm high abutment with cylindrical shape

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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Universitat de València

Valencia, Valencia, 46010, Spain

RECRUITING

Study Officials

• María I Suárez Antoima, DDS

  Universitat de València

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan C Bernabeu Mira, DDS, MSc, PhD

CONTACT

+34 697348312; juan.c.bernabeu@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

ES (1)