MARGINAL BONE LEVELS AROUND IMPLANTS PLACED BY PARTIAL OR FULL-THICKNESS FLAP: A 3-YEAR RANDOMIZED CONTROLLED CLINICAL TRIAL

Phase 4

Completed

• Conditions: Dental Implant; Dental Implant Therapy; Edentulism

• Registration Number: NCT06926101
• Lead Sponsor: University of Milan

Brief Summary

Each enrolled patient received one implant placed with the partial-thickness flap disconnect mode (PT Test Group) or the full-thickness flap disconnect mode (FT Control Group) from the same implant system (Anyridge, MegaGen Implant Co., Gyeongbuk, South Korea). Each implant was placed at 0.5 mm sub-crest as per protocol guidelines. This choice was made according to the current scientific literature. This implant system has specific macrostructural and microstructural techniques that allow high levels of standards. The fixture-abutment connection is internally conical at 2.8 mm with 5° indexing: this feature makes it possible to reduce the prosthetic microgap, move the platform away from the bone margin while maintaining an optimal crestal margin and prevent rotation or unscrewing of the prosthetic component. Each implant was placed at 1 mm sub-crest as per protocol guidelines. This choice was made according to the current scientific literature.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-31
• Status Verified: 2025-04
• Study First Submitted: 2025-04-06
• Study First Submitted QC: 2025-04-06
• Last Update Submitted: 2025-04-06
• Study First Posted: 2025-04-13
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 1. ≥18 years of age; 2. Need for implant placement therapy in the posterior area (from the second premolar to the second molar) due to a failing tooth; 3. Presence of adjacent and opposing natural teeth; 4. Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration; 5. Sufficient apical bone to achieve a minimum primary stability of 30Ncm.

Exclusion Criteria

• 1. Diagnosis of periodontal disease; 2. Medical or general contraindications for the surgical procedure, such as systemic diseases, history of head and neck radiation therapy, current steroid treatment, neurological or psychiatric conditions affecting oral hygiene, immune-compromised status, severe clenching, or bruxism; 3. Heavy smoking (>10 cigarettes/day); 4. Active infection at the implant site.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
marginal bone levels	each year up to 3 years

Trial Locations

Locations (1)

Dental Clinic University of Milan; 🇮🇹 Milano, Italy