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CompletedNCT05363306Updated May 5, 2022

Apico-coronal Position of Tissue-level Implants Bone Stability

An observational study in Bone Atrophy, Alveolar, sponsored by International Piezosurgery Academy. Completed at 2 sites in Italy. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-05.

Sponsored by International Piezosurgery Academy · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
20 Years and older
Sex
All
01

Study summary

early marginal bone loss around dental implants may hamper long term prognosis of implant-prosthetic rehabilitation. this study aimed to study the correlation of pico-coronal position of dental implant (from supracrestal, crystal to undergone level) measuring early marginal bone loss through periapical x-ray at surgical time and subsequent follow-ups.

Read the detailed description

Early marginal bone loss (EMBL) is a non-infective remodeling process of peri-implant crestal bone occurring within the first year after implant insertion. EMBL has a multifactorial etiology, being influenced by various surgical and prosthetic factors, including insufficient crestal width, surgical trauma, biological width formation, microbial colonization of implant-abutment micro-gap, horizontal implant-abutment mismatch ("the platform-switching concept"), the number of abutment connection/disconnections, prosthetic abutment height, design and mechanical stability of implant-abutment connection and adaptive response to occlusal loading.

Biological width formation is the main factor influencing peri-implant marginal bone adaptive processes prior to prosthesis delivery. When an implant gets exposed to the oral cavity, soft tissues establish a cuff-like barrier sealing the trans-epithelial component of the fixture.

Differently from equicrestal and subcrestal implants, which present a microgap between implant and abutment at the marginal bone level, tissue-level implants have no gap at this region.

The present multicenter prospective study aims to evaluate if EMBL occurring around tissue-level dental implants before prosthesis delivery may be reduced by adapting apico-coronal positioning in relation to supracrestal tissue thickness.

All patients are treated according to one-stage implant. Sutures are removed 12-14 days after surgery. No removable prostheses are utilized during the healing period.

Final impressions were taken five months after the implant placement. After functional and aesthetic try-in, a single-unit screw-retained metal ceramic crown is delivered. The fixation screw was torqued to 30Ncm following manufacturer's guidelines. Screw access is then closed using light-cured composite resin.

Radiographic measurements. Digital radiographs, customized for each patient with a bite jig, are taken using a long-cone paralleling technique with a film holder at the time of implant placement (baseline, T0), 3 months after implant placement (T1), and 5 months after implant placement, immediately before impression taking (T2). All radiographs are performed using the same x-ray generator technology, set with the same parameters (60 kV, 7 mA).

Two different types of bone changes are calculated, as suggested elsewhere.

  1. Early marginal bone loss (EMBL) is calculated.
  2. Bone Loss Exposing Implant Surface (BLEIS) is calculated as the difference between the EMBL measurement and the 3 mm length of the transmucosal, machined portion of the implant.

Radiographs demonstrating any deformation, darkness and/or other problem are immediately repeated. All measurements are made by a single calibrated examiner, blind to mucosal thickness, using a 30-inch led-backlit color diagnostic display with Kodak Digital Imaging Software. Each measurement is repeated three times at three different time points as proposed by Gomez-Roman and Launer. Intra-examiner and inter-examiner concordances are 96.1% and 90.4%, respectively, for linear measurements within ±0.1mm.

02

Conditions studied

  • Bone Atrophy, Alveolar

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Keywords

  • osseointegrated implant; early marginal bone loss;
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In context

Alveolar Bone Loss

297 studies on the registry are indexed under Alveolar Bone Loss; 76 are open to participants now.

This study's enrollment of 50 is close to the median of 54 across 40 observational studies indexed under Alveolar Bone Loss.

Browse Alveolar Bone Loss studies →

Lead sponsor

International Piezosurgery Academy is the lead sponsor of 24 studies on the registry; 3 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients were partially edentulous and required placement of at least one single delayed implant in pristine bone in the posterior mandible

Inclusion criteria

  • Patients were partially edentulous and required placement of at least one single delayed implant in pristine bone in the posterior mandible
  • presence of keratinized mucosa with a minimum bucco-lingual width of 3 mm;
  • bone crest with at least 6mm of width and 9 mm of height above the mandibular canal without concomitant or previous bone augmentation procedures;
  • presence of the opposing dentition

Exclusion criteria

Exclusion Criteria:

  • smokers
  • uncontrolled periodontitis
  • medication consumption for at least 3 months prior to treatment
  • history of head or neck radiation therapy
  • pregnancy or lactating at any time during the study
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • thin crestal mucosa

    Based upon vertical mucosa thickness measured at implant placement, implants were placed: 2mm below the crestal bone in presence of thin mucosa (\< 2.5mm)

    Procedure: implant insertion

  • medium crestal mucosa

    Based upon vertical mucosa thickness measured at implant placement, implants were placed: 2) 1mm below the crestal bone in presence of medium mucosa (2.5-3.5mm);

    Procedure: implant insertion

  • thick crestal mucosa

    Based upon vertical mucosa thickness measured at implant placement, implants were placed: 1) at crestal level in presence of thick mucosa (\> 3.5 mm);

    Procedure: implant insertion

Interventions

  • Procedureimplant insertion

    4% articaine solution, a mid-crestal incision along the center of the edentulous bone ridge was performed. A full-thickness flap was elevated. The sites were prepared to permit insertion of transmucosal, external hex, implants (I-smart, I-RES, Lugano, Switzerland) at three different crestal levels, based upon vertical mucosa thickness measured at implant placement. Owing to width crest, all implants were 3.75 mm in diameter and operators selected appropriate implant lengths (8, 10 mm) according to available bone crest height. All implants were not submerged and flaps were sutured around the transmucosal component.

06

What researchers measure

Primary outcomes

  1. early marginal bone loss

    distance from crystal bone to most coronal bone to implant contact

    Time frame: 5 months after implant placement

Secondary outcomes

  1. biological complications

    any surgical complication

    Time frame: during surgery

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Study locations

2 sites
  • Hesire
    Cassano allo Ionio, CS 87011, Italy
  • Piezosurgery Academy
    Parma, 43100, Italy
08

References and documents

Publications

  • Lombardi T, Berton F, Salgarello S, Barbalonga E, Rapani A, Piovesana F, Gregorio C, Barbati G, Di Lenarda R, Stacchi C. Factors Influencing Early Marginal Bone Loss around Dental Implants Positioned Subcrestally: A Multicenter Prospective Clinical Study. J Clin Med. 2019 Aug 4;8(8):1168. doi: 10.3390/jcm8081168. PubMed 31382675 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05363306
Lead sponsor
International Piezosurgery Academy
Responsible party
Sponsor
First posted
May 5, 2022
Start date
Jan 1, 2021
Primary completion
Jul 1, 2021
Completion
Mar 1, 2022
Last update
May 5, 2022

Study contacts

Teresa Lombardi, Dr.
principal investigator · Hesire dental office

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 May 2022. You cannot join it, but the record below documents what was studied.

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