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

NCT06926101 | Completed Phase 4

• 1 other identifier: 1564/19
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant; Dental Implant Therapy; Edentulism

Outcome Measures

Primary Outcomes (1)

• marginal bone levels

  each year up to 3 years

Study Arms (2)

Implant placement through partial thickness flap procedure

EXPERIMENTAL

Device: dental implants

Implant placement through full thickness flap procedure

ACTIVE COMPARATOR

Device: dental implants

Interventions

dental implants DEVICE

dental implant placement by full or partial thickness flap

Implant placement through full thickness flap procedure; Implant placement through partial thickness flap procedure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. ≥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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Dental Clinic University of Milan

Milan, 20131, Italy

Location

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MSc, MClindDent (Oral Surgery), PhD

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 13, 2025
• Study Start: January 1, 2019
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)