Manual or Digitally Guided Surgical Technique for Replacing Single Tooth Edentulism by Means of Sub-crestally Placed Implants. A 3-year Parallel Randomized Clinical Study on Marginal Bone Levels Stability

Not Applicable

Completed

• Conditions: Supral Tissue Height; Dental Implant; Marginal Bone Loss; Peri Implant Health
• Interventions: Procedure: Implant placement

• Registration Number: NCT06250621
• Lead Sponsor: ASST Santi Paolo e Carlo

Brief Summary

The aim of the present prospective study was to investigate after a 2-year of follow-up any influence of the surgical technique, manual or digitally guided, on peri-implant marginal bone levels stability in implants placed 1 mm sub-crestally.

Patients were treated by means of platform-switched implants provided with a 5 degrees internal conical connection and supporting single screw-retained fixed crowns. Marginal bone level (MBL) measured at prosthesis installation (t0) at 1 (t1), 2 (t2) and at 3 years of follow-up visit (t3) were considered. MBL change from t0 to t3 was investigated. The distance between the implant neck and the first radiographically detected bone to implant contact was considered to evaluate the bone loss. Two groups were considered: Test Group (GD) for implant sites treated with a digitally guided surgery procedure. Control Group (FH) for implants surgically placed without digitally guided surgery, respectively. All the procedures were performed by an experienced operator. Additionally, for both groups MBL changes were correlated to different supra-crestal soft tissue height (STH) amounts: less than 3 and ≥ 3 millimeters, respectively. Peri-implant soft tissue parameters such as probing depth (PPD), modified Sulcus Bleeding Index (mBI) and modified Plaque Index (mPI), were assessed for all the restorations included.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-10
• Primary Completion: 2021-05-15
• Study Completion: 2023-10-20
• Status Verified: 2024-01
• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-01
• Last Update Submitted: 2024-02-01
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• absence of mandibular and/or maxillary atrophy; presence of partial edentulism of at least one pair of elements and adequate amount of bone tissue to be able to insert an implant, i.e., a minimum amount of residual bone of 5 mm in thickness and 10 mm in height; presence of an antagonistic element with respect to the tooth to be rehabilitated.

Exclusion Criteria

• patients presenting with a clinical history of systemic diseases and metabolic deficits, presence or previous leukocyte dysfunction/deficiency, blood disorders, hemophilia, dicoumarolic drug therapy, treatment of prolonged steroid therapy, history of neoplasms resulting in chemotherapy and/or radiation therapy in the head and neck district, history of chronic renal problems, chronic liver disease, bone metabolism disorders, uncontrolled endocrine disorders, and ongoing pregnancy and/or lactation. presence of local inflammation such as untreated periodontitis, bruxism condition or clenching habit, habitual oral infections, mucosal disorders (erosive lichen planus), oral lesions (ulcers, malignant lesions), inadequate oral hygiene, and poor compliance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Group (GD)	Implant placement	in this group were considered implant sites treated with a digitally guided surgery procedure
Control Group (FH)	Implant placement	in this group were considered implant sites treated without a digitally guided surgery procedure

Primary Outcome Measures

Name	Time	Method
Marginal bone loss	From t0 to t3 (3-years of follow up)	Measurements were made at mesial and distal aspect of each implant and were reported in millimeters.; Because of implants were sub-crestally positioned, measurements where bone was under the implant to abutment level were classified as negative values. On the contrary, measurements where implant neck was over the bone crest were classified as positive values.; Measurements were made at mesial and distal aspect of each implant and were reported in millimeters.; Because of implants were sub-crestally positioned, measurements where bone was under the implant to abutment level were classified as negative values. On the contrary, measurements where implant neck was over the bone crest were classified as positive values.

Secondary Outcome Measures

Name	Time	Method
STH	During surgery	After flap elevation the height of the supra-crestal soft tissue (STH) was measured by means of a calibrated probe.

Trial Locations

Locations (1)

ASST Santi Paolo e Carlo; 🇮🇹 Milan, MI, Italy