Evaluation of Using Different Screwed Abutment Height

NCT06017115 | Completed Results DMC

• 1 other identifier: CIR-ECL-2016-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Bone Loss

Keywords

bone loss; dental implant; bone implant interface; Peri implant Endosseous Healing; Dental implant abutment

Outcome Measures

Primary Outcomes (1)

• Marginal Bone Loss

  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.

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

Secondary Outcomes (3)

• Probing Depth

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

• Bleeding on Probing

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

• Keratinized Mucosa Width

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

Study Arms (2)

Control group

ACTIVE COMPARATOR

Group 1: 2 stage approach (cover screw) (12 patients): cover screw is placed over the dental implants in the first surgery and a second surgery will be performed to expose the implants and placing a healing abutment after 2-4 months, DEVICES: COVER SCREW (first surgery) and HEALING ABUTMENT (second surgery)

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

Test group

EXPERIMENTAL

Group 2: Protective plastic cap over different definitive trans-epithelial abutments are placed in the unic surgery performed (36 patients): Definitive transepithelial abutments will be placed the same day of the implant placement surgery. DEVICE: DEFINITIVE TRANSEPITHELIAL ABUTMENT

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

Interventions

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)

Control group; Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Barcelona, 08195, Spain

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Dr. Jordi Gargallo
• Organization: Universitat Internacional de Catalunya

jgargallo@uic.es

+34 935 04 20 00

Study Officials

• Jordi Gargallo-Albiol

  Universitat Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Associate Professor of Oral and Maxillofacial Surgery

Model Details: Each patient will be randomly allocated in one of the two groups: test group (n=36) or control group (n=12)

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: August 30, 2023
• Study Start: July 1, 2017
• Primary Completion: July 30, 2022
• Study Completion: November 1, 2024
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The first outcome will be available in July-2022 and the last outcome in July.2024

Locations

ES (1)