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CompletedNCT06926101Updated Apr 13, 2025

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

A Phase 4 interventional study of dental implants in Dental Implant, Dental Implant Therapy and Edentulism, sponsored by University of Milan. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-13.

Sponsored by University of Milan · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 3 months after the study started (first participant enrolled Jan 2019, registered Apr 2025).
Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dental Implant
  • Dental Implant Therapy
  • Edentulism
03

In context

Lead sponsor

University of Milan is the lead sponsor of 177 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Implant placement through partial thickness flap procedure

    Device: dental implants

  • Active comparator
    Implant placement through full thickness flap procedure

    Device: dental implants

Interventions

  • Devicedental implants

    dental implant placement by full or partial thickness flap

06

What researchers measure

Primary outcomes

  1. marginal bone levels

    Time frame: each year up to 3 years

07

Study locations

1 site
  • Dental Clinic University of Milan
    Milano, 20131, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06926101
Lead sponsor
University of Milan
Responsible party
Antonino Palazzolo (DDS, MSc, MClindDent (Oral Surgery), PhD, University of Milan) — Principal investigator
First posted
Apr 13, 2025
Start date
Jan 1, 2019
Primary completion
Jun 30, 2024
Completion
Jul 31, 2024
Last update
Apr 13, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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