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OpenTrials
Completed

NCT Number: NCT06926101

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

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.

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Key information

Conditions

Dental Implant Dental Implant Therapy Edentulism

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dental Clinic University of Milan

Milan, 20131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dental implants

Device

dental implant placement by full or partial thickness flap

Primary outcomes

  1. marginal bone levels

    Time frame: each year up to 3 years

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 13, 2025
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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