Evaluation of Implant Stability Changes in Sites Prepared with Different Osseodensification Techniques: a Prospective Observational Clinical Study

NCT06679894 | Completed DMC

• 1 other identifier: 2024-IND-9
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to compare, within a cohort of patients requiring rehabilitation in two different sites of the premolar area in the upper maxilla, the primary and secondary stability of implants placed in sites prepared using a magnetic mallet and osseodensification burs.

Conditions

Edentulous; Alveolar Process Atrophy

Outcome Measures

Primary Outcomes (2)

• Implant primary stability

  Insertion torque

  At implant insertion

• Implant primary stability

  Resonance frequency

  At implant insertion

Secondary Outcomes (7)

• Implant secondary stability

  7 days after implant insertion

• Implant secondary stability

  14 days after implant insertion

• Implant secondary stability

  21 days after implant insertion

• Implant secondary stability

  28 days after implant insertion

• Implant secondary stability

  60 days after implant insertion

Other Outcomes (3)

• Peri-implant marginal bone level stability

  Immediately after surgery

• Peri-implant marginal bone level stability

  Upon delivery of prosthetic rehabilitation (6 months after surgery)

• Peri-implant marginal bone level stability

  One year of loading

Study Arms (2)

Single tooth edentulism right

single missed teeth

Procedure: Implant site preparation with osteotomes and electrified mallet

single tooth edentulism left

single missed tooth

Procedure: Implant site preparation with osseodensification drills

Interventions

Implant site preparation with osteotomes and electrified mallet PROCEDURE

Under local anesthesia (mepivacaine HCL 2% with epinephrine1:100.000), a minimally invasive full-thickness flap was elevated to expose the alveolar crest. A pilot osteotome (100-P) was used to easily perforate the cortical plate. Subsequently, osteotomes with gradually increasing diameters were employed until the final diameter of 3.2 mm was reached. The sequence of osteotomes and their respective diameters were as follows: 1. Osteotome 100-P: At a height of 8.5 mm, the diameter was 2.2 mm; 2. Osteotome 160: At a height of 8.5 mm, the diameter was 2.8 mm; 3. Osteotome 200: At a height of 8.5 mm, the diameter was 3.2 mm. Implant (4.0x8.5 mm; Anyridge, Megagen, Gyeongbuk, South Korea) was positioned using a surgical motor. A 3 mm high transepithelial abutment (OCTA, Megagen, Gyeongbuk, South Korea) was connected to it using a torque wrench and it was tightened to 30 Ncm. Single sutures in monofilament synthetic polypropylene 4.0 were performed to close flaps around the abutment.

Single tooth edentulism right

Implant site preparation with osseodensification drills PROCEDURE

Under local anesthesia (mepivacaine HCL 2% with epinephrine1:100.000), a minimally invasive full-thickness flap was elevated to expose the alveolar crest. The implant site preparation was realized using osseodensification burs at a rotation speed of 1200 rpm. The osseodensification burs sequence was as follows: 1. Initial pilot hole (rotated clockwise); 2. WT1828 bur (rotated counterclockwise), 3. WT2838 bur (rotated counterclockwise). Implant (4.0x8.5 mm; Anyridge, Megagen, Gyeongbuk, South Korea) was positioned using a surgical motor. A 3 mm high transepithelial abutment (OCTA, Megagen, Gyeongbuk, South Korea) was connected to it using a torque wrench and it was tightened to 30 Ncm. Single sutures in monofilament synthetic polypropylene 4.0 were performed to close flaps around the abutment.

single tooth edentulism left

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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:

• Age older than 18 years old;
• Indication for an implant-supported rehabilitation in the upper premolar / first molar areas;
• The area in which the implants will be placed must have had at least 6 months of healing;
• No use of grafts or bone substitutes following tooth extraction;
• Bone volume measuring at least 10 mm in height and 6 mm in width;
• In case of two adjacent implants the distance between the natural teeth must be at least 14 mm, composed by twice the width of each implant (4 mm), the distance between them (at least 3 mm) and twice the distance between each teeth (at least 1,5 mm)
• Bone quality belonging to class D3 or D4, following Misch classification
• Absence or decision to not wear a removable prosthesis during the healing period;
• Patients with good and stable oral hygiene;
• Signed informed consent form.

You may not qualify if:

• Acute myocardial infarction within the previous six months;
• Uncontrolled bleeding disorders;
• Uncontrolled diabetes (HBA1c \> 7.5%);
• Radiotherapy in the head-neck area in the previous 48 months;
• Immunocompromised patients (es. AIDS / chemotherapy);
• Current or previous treatment with antiresorptive drugs via intravenous injection;
• Psychological or psychiatric disease;
• Alcohol and /or drugs abuse;
• Heavy smokers (more than 10 cigarettes / day);
• Plaque index \>20% and/or bleeding on probing \>10%
• Pregnant or breastfeeding patients;
• Patients refusing to participate in follow-up checks.

Sponsors & Collaborators

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

Study Sites (1)

Piezosurgery Academy

Parma, Italy, 43100, Italy

Location

MeSH Terms

Conditions

Mouth, Edentulous; Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases

Study Design

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

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 8, 2024
• Study Start: February 15, 2024
• Primary Completion: July 15, 2024
• Study Completion: November 5, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)