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Completed

NCT Number: NCT06017115

Evaluation of Using Different Screwed Abutment Height

A prospective randomized controlled clinical trial will be conducted. Study groups will be assigned as described above. The patients will be randomly divided into two groups in order to study the influence of prosthetic screw abutment in marginal bone loss (MBL) around Bone Level Tapered implants (BLT® Roxolid® SLActive® guided implants, Straumann Dental Implant System, Institut Straumann AG, Basel, Switzerland).

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Key information

Conditions

Bone Loss Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat Internacional de Catalunya

Barcelona, 08195, Spain

About this study

48 patients will be selected with partial edentulism in the maxilla or mandible, requiring two dental implants in the posterior areas (molars and premolars).

Each patient will be randomly allocated in one of the two groups: test group (n=36) or control group (n=12) and all the implants will be placed by residents of the International Master in Oral Surgery and Master in Periodontics of the same University.

Study groups

Group 1: Two stage approach (cover screw in first surgery and healing abutment in second surgery) (12 patients)

Group 2: One stage approach (healing cap over trans-epithelial abutments) (36 patients).Two subgroups according to different trans-epithelial height abutment:

  • Subgroup 2.1: Screw-retained abutment of 1 mm height (18 patients)
  • Subgroup 2.2: Screw-retained abutment of 2.5 mm height (18 patients)

Clinical Parameters and Outcomes

  • Three-dimensional volumetric changes in hard and soft tissues (Cone-beam computed tomography superposed with digital cast models).
  • Marginal bone level (MBL) change: Standardized intraoral periapical x-rays will be taken on the day of surgery, 4, 6, 12, 24 and 36 months following surgery.
  • Probing depth, bleeding on probing and keratinized mucosa width will be measured in the follow-up visits in 3 different points in buccal (Mesial, center and distal).
  • VAS Scale: The visual analog scale or visual analog scale (VAS).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • Overall, healthy subjects
  • Females and males of at least eighteen-years
  • Requiring a minimum of two implants (molar and/or premolar teeth)
  • Adequate oral hygiene (less than 15% FMPS)
  • Able to follow instructions and attend a regular compliance
  • Enough bone to place a standard implant of 4.1 mm diameter.

Exclusion criteria

  • Acute local infection
  • Occlusal overload with parafunctional activity (assessed clinically)
  • Large occlusal discrepancies
  • Untreated periodontal disease assessed by Socransky et al. parameters (≥2mm clinical attachment loss in two consecutive visits within 1 year)
  • Smokers (more than 10 cigarettes/day)
  • Drug and/or alcoholic dependencies
  • Medical conditions contraindicating implant surgery
  • History of head and/or neck radiation
  • Bisphosphonate therapy

Treatment and study plan

Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group)

Device

Dental implant placement using cover screws (first surgery) and a healing abutment (second surgery) or definitive transepithelial abutments the same day of the implant placement (one unit surgery)

Primary outcomes

  1. Marginal Bone Loss

    Time frame: After implant loading (baseline)and once every year to 24 months follow-up

    Periimplant bone level by measuring from the implant platform to the first bone to implant contact. Messuret in 2 points: MESIAL AND DISTAL with intra-oral XR. (measured in millimeters). The mean of this two-points for each implant was calculated. Afterwards, the mean for the mesial implants, distal and total implant sample per group was calculated.

Secondary outcomes

  1. Probing Depth

    Time frame: After implant loading (baseline)and once every year to 36 months follow-up

    Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters).

  2. Bleeding on Probing

    Time frame: After implant loading (baseline)and once every year to 36 months follow-up

    Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters).

  3. Keratinized Mucosa Width

    Time frame: After implant loading (baseline)and once every year to 36 months follow-up

    Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters).

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Official study title

Evaluation of Straumann Bone Level Tapered® Implants Using Screwed Abutment Height in Partially Edentulous Patients: a Randomized Controlled Clinical Trial

Important dates

Study start
2017
Primary completion
2022
Study completion
2024
First posted
Aug 30, 2023
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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