Influence of Implant Insertion Torque on Post-Surgical Marginal Bone Stability

NCT07019480 | Active Not Recruiting

• 1 other identifier: MEGAWH 1.0
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective, multicenter observational study is to evaluate the influence of various surgical parameters (maximum insertion torque; average insertion torque; final insertion torque; area under the torque curve; intercept and slope of the least squares regression line of the torque curve; implant stability quotient measured immediately after implant insertion) on implant osseointegration and on peri-implant marginal bone loss occurring during the first three months of submerged healing.

Conditions

Edentulous Alveolar Ridge

Outcome Measures

Primary Outcomes (3)

• Implant Stability Quotient (ISQ) for the evaluation of primary stability, measured using a resonance frequency analysis (RFA) device (Osstell).

  Resonance Frequency Analysis (RFA) device (Osstell, Göteborg, Sweden) with the appropriate transducer for the selected abutment (Smartpeg Type 05, Osstell, Göteborg, Sweden). ISQ will be measure in the mesio-distal, disto-mesial, bucco-lingual, and linguo-buccal directions.

  Immediately after implant placement

• Implant primary stability in Newton

  Insertion torque

  During the full course of implant insertion

• Periapical radiograph for the assessment of peri-implant bone level (PBL) in millimeters

  Periapical radiograph using a customized Rinn-type film holder for each patient with the aid of a silicone index

  Immediately after implant placement

Secondary Outcomes (7)

• Implant Stability Quotient (ISQ) for the evaluation of secondary stability, measured using a resonance frequency analysis (RFA) device (Osstell)

  3 months after implant insertion

• Periapical radiograph for the assessment of peri-implant bone level (PBL) in millimeters

  3 months after implant insertion

• Periapical radiograph for the assessment of peri-implant bone level (PBL) in millimeters

  upon prosthesis delivery

• Periapical radiograph for the assessment of peri-implant bone level (PBL) in millimeters

  6 months after prosthetic loading

• Periapical radiograph for the assessment of peri-implant bone level (PBL) in millimeters

  1 year after prosthetic loading

Study Arms (1)

cohort

implant insertion with recorded torque and stability values

Procedure: implant insertion

Interventions

implant insertion PROCEDURE

Following local anesthesia (articaine 4% with epinephrine 1:100,000), a minimally invasive full-thickness flap will be elevated. Implant site preparation will be performed with twist drills and the implant will be inserted. Implant stability (ISQ) will be measured in the mesio-distal, disto-mesial, bucco-lingual, and linguo-buccal directions using a resonance frequency analysis device (Osstell Beacon, Osstell, Göteborg, Sweden) with a single-use magnetic peg specific to the implant (SmartPeg Type 07, Osstell, Göteborg, Sweden). The flap will be closed using non-resorbable monofilament sutures, and the implant will be submerged (two-stage protocol).

cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

After investigating general and local anamnesis, which included evaluation of systemic illnesses and potential allergies, a dental visit was conducted to formulate a specific treatment plan. If the patient was deemed eligible for the research protocol, an additional periapical radiograph was obtained for each selected site to assess the adequacy of residual bone height. If the available bone height appeared to be sufficient, a second-level radiographic exam, a Cone Beam Computed Tomography (CBCT), was performed to evaluate whether the bone volume was adequate for supporting implant rehabilitation. For patients requiring tooth extraction, this second assessment was performed after six months of healing after extraction.

You may qualify if:

• Indication for implant-supported prosthetic rehabilitation of single or multiple partial edentulism in one or both arches, based on accurate diagnosis and treatment planning;
• The area in which the implants will be placed must have had at least 6 months of healing;
• Residual alveolar ridge width ≥7 mm;
• Available bone height \>9 mm at the planned implant site;
• Patient aged \>18 years;
• Patient does not use any removable prosthesis at the site to be treated;
• Patient is able and willing to comply with the study protocol;
• Patient signs the written informed consent.

You may not qualify if:

• Acute myocardial infarction within the past two months;
• Uncontrolled bleeding disorders;
• Uncontrolled diabetes (HBA1c \> 7.5);
• History of head and/or neck radiotherapy within the past 24 months;
• Immunocompromised patients, HIV positive, or undergoing chemotherapy within the past five years;
• Current or previous antiresorptive therapy;
• Psychological or psychiatric disorders;
• Drug or alcohol abuse.

Sponsors & Collaborators

• International Piezosurgery Academy: lead
• University of Trieste: collaborator

Study Sites (1)

University of Trieste

Trieste, TS, 34125, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2035
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)