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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06926101
Enrollment
70
Registered
2025-04-13
Start date
2019-01-01
Completion date
2024-07-31
Last updated
2025-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant, Dental Implant Therapy, Edentulism

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.

Interventions

DEVICEdental implants

dental implant placement by full or partial thickness flap

Sponsors

University of Milan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
marginal bone levelseach year up to 3 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026