AzTrials
AzTrials

Alveolar Bone Lossi-RESNCT03229005

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

A study testing implant insertion, operculectomy and prosthetic rehabilitation in people with Alveolar Bone Loss, run by International Piezosurgery Academy at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Alveolar Bone Loss
What is being tested?
implant insertion, operculectomy and prosthetic rehabilitation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteItaly
Study dates
15 May 2017to 15 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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;
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Piezosurgery Academy

    Parma, PR, 43100

Other trials in Italy

About this study

Official title: Influence of Soft Tissue Width and Abutment Height on Peri-implant Bone Resorption: a Clinical and Radiographic Multicenter Study

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.

Being tested
implant insertion, operculectomy, prosthetic rehabilitation
Keywords
soft tissue; implant; abutment;
Medical subject headings
Alveolar Bone Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • implant insertionProcedure or surgery

    during surgery soft tissues will be measured

  • operculectomyProcedure or surgery

    during second surgery soft tissues will be measured again

  • prosthetic rehabilitationProcedure or surgery

    after three months implants will be loaded with screw retained crown

Study groups in NCT03229005
Study groupRoleWhat they receive
A1 thick-highActive comparatorgroup with thick tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation
Receives: Procedure: implant insertion; Procedure: operculectomy; Procedure: prosthetic rehabilitation
A2 thick-lowExperimentalgroup with thick tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation
Receives: Procedure: implant insertion; Procedure: operculectomy; Procedure: prosthetic rehabilitation
B1 thin-highActive comparatorgroup with thin tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation
Receives: Procedure: implant insertion; Procedure: operculectomy; Procedure: prosthetic rehabilitation
B2 thin-lowExperimentalgroup with thin tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation
Receives: Procedure: implant insertion; Procedure: operculectomy; Procedure: prosthetic rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. peri-implant bone resorption

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

    Measured: after 12 months

  2. implant survival

    clinical and radiographical examination

    Measured: after 12 months

Secondary outcomes (5)
  1. peri-implant bone resorption

    intraoral radiographs will be acquired

    Measured: immediately after surgery (baseline)

  2. peri-implant bone resorption

    intraoral radiographs will be acquired

    Measured: four months after surgery (at prosthesis delivery)

  3. peri-implant bone resorption

    intraoral radiographs will be acquired

    Measured: six months after prosthetic loading

  4. peri-implant bone resorption

    intraoral radiographs will be acquired

    Measured: 24 months after prosthetic loading

  5. complications and/or adverse events

    clinical and radiographical examination

    Measured: any time of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2017
  2. Study start15 May 2017
  3. Primary completion15 Oct 2018
  4. Study completion15 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03229005
Sponsor's protocol ID
i-RES
Acronym
i-RES
Status last verified
Aug 2019
First submitted
22 Jul 2017
Last updated
28 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing implant insertion, operculectomy and prosthetic rehabilitation in people with Alveolar Bone Loss, run by International Piezosurgery Academy at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

peri-implant bone resorption (time frame: after 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03229005, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in