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CompletedNCT03229005i-RESUpdated Aug 28, 2019

Soft Tissue Width and Abutment Height Influence Peri-implant Bone Resorption

An interventional study of implant insertion and operculectomy in Alveolar Bone Loss, sponsored by International Piezosurgery Academy. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by International Piezosurgery Academy · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this clinical and radiographic study will be to determine what influence on marginal bone loss has the thickness of soft tissues and the height of the prosthetic abutment and eventually determine which of the two factors is the most important.This research was designed as a multicentre cohort study. Two clinical centers will treat patients through the placement of a single dental implant. The implants will be prosthetically loaded about 4 months after placement and periapical radiographs will be acquired at each time-point.

Read the detailed description

The purpose of this clinical and radiographic study will be to determine what influence on marginal bone loss has the thickness of soft tissues and the height of the prosthetic abutment and eventually determine which of the two factors is the most important.This research was designed as a multicentre cohort observational study. Two clinical centers will treat patients through the placement of a single dental implant. The implants will be prosthetically loaded about 4 months after placement and periapical radiographs will be acquired at each time-point.

All patients will receive antibiotic prophylaxis with 2 g of amoxicillin one hour before surgery. With the help of a dissector, a full thickness vestibular flap will be carefully arranged and the vertical thickness of soft tissues will be measured with a probe marked every 1.0 mm. If the vertical thickness of the soft tissue is 2 mm or less, the tissue will be considered thin. If the thickness of the mucosa is greater than 2 mm, it will be considered thick. After the measurement, the lingual flap will be elevated at full thickness, and the site for site placement will be prepared. The implant bed will be at least 1.5 mm from the adjacent tooth or teeth, and must be surrounded by at least 1 mm bone in both buccal and lingual directions. A 3,75 mm diameter and internal hexagonal connection implant will be placed at the level of the bone crest according to the manufacturer's recommendations. Operators will be free to choose the most suitable system length (8, 10, 11.5 mm). All implants will be submerged according to a traditional two-stage protocol. After insertion, the flaps will be sutured without tension with interrupted sutures. Patients of both groups will be instructed to disinfect the site by rinsing twice daily for one week for 1 minute with 0.12% chlorhexidine. After 4 months of healing, the treated area will be reopened for connecting the healing abutments with a crestal incision that will retain the keratinized tissue; The same soft tissue measurements will be repeated as confirmation of what was done during the first surgical implant insertion phase. The implants will be considered osteointegrated successfully if they are clinically intact unless they show obvious radiotransparency and patients will not report any pain. After this step, it will be possible to divide the patients into 2 groups according to the thickness of the soft tissue: a group with thick tissue (more than 2.0 mm); Slim tissue group (less than 2.0 mm). The prosthetic framework will be bonded directly to prefabricated titanium abutment (1 or 3 mm). This will result in the formation of 4 different subgroups: a group with thick tissue and high prosthetic abutment; A group with thick tissue and low prosthetic stump; a group with thin tissue and high prosthetic abutment; a group with thin tissue and low prosthetic abutment.

All the implants will be rehabilitated by the dentist with screwed restorations. After prosthetic treatment, patients will receive oral hygiene instructions and will be monitored through calls to ensure periodontal health throughout the study period.

02

Conditions studied

  • Alveolar Bone Loss

Keywords

  • soft tissue; implant; abutment;
03

In context

Bone Resorption

153 studies on the registry are indexed under Bone Resorption; 25 are open to participants now.

This study's enrollment of 70 is above the median of 22 across 133 interventional studies indexed under Bone Resorption.

Browse Bone Resorption 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
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

General inclusion criteria were:

  • age>18 years;
  • good general health;
  • non smokers;
  • absence of systemic diseases affecting bone metabolism and wound healing; - no regular medication consumption for at least 3 months prior to treatment; - patient willing and fully capable to comply with the study protocol;
  • written informed consent given.

Local inclusion criteria were:

  • presence of keratinized mucosa with a minimum bucco-lingual width of 3 mm; - bone crest with at least 6 mm 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 were:

  • history of head or neck radiation therapy;
  • uncontrolled diabetes (HBA1c >7.5%);
  • active infections;
  • immunocompromised patients (HIV infection or chemotherapy within the past 5 years);
  • present or past treatment with intravenous bisphosphonates;
  • patient pregnancy or lactating at any time during the study;
  • poor oral hygiene and motivation;
  • untreated periodontal disease;
  • psychological or psychiatric problems;
  • alcohol or drugs abuse;
  • participating in other studies, if the present protocol could not be properly followed;
  • lack of implant primary stability.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    A1 thick-high

    group with thick tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation

    Procedure: implant insertion · Procedure: operculectomy · Procedure: prosthetic rehabilitation

  • Experimental
    A2 thick-low

    group with thick tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation

    Procedure: implant insertion · Procedure: operculectomy · Procedure: prosthetic rehabilitation

  • Active comparator
    B1 thin-high

    group with thin tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation

    Procedure: implant insertion · Procedure: operculectomy · Procedure: prosthetic rehabilitation

  • Experimental
    B2 thin-low

    group with thin tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation

    Procedure: implant insertion · Procedure: operculectomy · Procedure: prosthetic rehabilitation

Interventions

  • Procedureimplant insertion

    during surgery soft tissues will be measured

  • Procedureoperculectomy

    during second surgery soft tissues will be measured again

  • Procedureprosthetic rehabilitation

    after three months implants will be loaded with screw retained crown

06

What researchers measure

Primary outcomes

  1. peri-implant bone resorption

    intraoral radiographs will be acquired and bone crest level will be compared with baseline

    Time frame: after 12 months

  2. implant survival

    clinical and radiographical examination

    Time frame: after 12 months

Secondary outcomes

  1. peri-implant bone resorption

    intraoral radiographs will be acquired

    Time frame: immediately after surgery (baseline)

  2. peri-implant bone resorption

    intraoral radiographs will be acquired

    Time frame: four months after surgery (at prosthesis delivery)

  3. peri-implant bone resorption

    intraoral radiographs will be acquired

    Time frame: six months after prosthetic loading

  4. peri-implant bone resorption

    intraoral radiographs will be acquired

    Time frame: 24 months after prosthetic loading

  5. complications and/or adverse events

    clinical and radiographical examination

    Time frame: any time of the study

07

Study locations

1 site
  • Piezosurgery Academy
    Parma, PR 43100, Italy
08

References and documents

Publications

  • Galindo-Moreno P, Leon-Cano A, Monje A, Ortega-Oller I, O'Valle F, Catena A. Abutment height influences the effect of platform switching on peri-implant marginal bone loss. Clin Oral Implants Res. 2016 Feb;27(2):167-73. doi: 10.1111/clr.12554. Epub 2015 Feb 11. PubMed 25678247 ↗
  • Linkevicius T, Apse P, Grybauskas S, Puisys A. Influence of thin mucosal tissues on crestal bone stability around implants with platform switching: a 1-year pilot study. J Oral Maxillofac Surg. 2010 Sep;68(9):2272-7. doi: 10.1016/j.joms.2009.08.018. PubMed 20605308 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03229005
Lead sponsor
International Piezosurgery Academy
Responsible party
Mr. Claudio Stacchi, DDS, MSc (President of the Academy, International Piezosurgery Academy) — Principal investigator
First posted
Jul 25, 2017
Start date
May 15, 2017
Primary completion
Oct 15, 2018
Completion
Jun 15, 2019
Last update
Aug 28, 2019

Study contacts

Claudio Stacchi, Dr.
principal investigator · Piezosurgery Academy

Oversight

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

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