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Soft Tissue Width and Abutment Height Influence Peri-implant Bone Resorption (i-RES)

Primary Purpose

Alveolar Bone Loss

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
implant insertion
operculectomy
prosthetic rehabilitation
Sponsored by
International Piezosurgery Academy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss focused on measuring soft tissue; implant; abutment;

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Piezosurgery Academy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

A1 thick-high

A2 thick-low

B1 thin-high

B2 thin-low

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

peri-implant bone resorption
intraoral radiographs will be acquired and bone crest level will be compared with baseline
implant survival
clinical and radiographical examination

Secondary Outcome Measures

peri-implant bone resorption
intraoral radiographs will be acquired
peri-implant bone resorption
intraoral radiographs will be acquired
peri-implant bone resorption
intraoral radiographs will be acquired
peri-implant bone resorption
intraoral radiographs will be acquired
complications and/or adverse events
clinical and radiographical examination

Full Information

First Posted
July 22, 2017
Last Updated
August 27, 2019
Sponsor
International Piezosurgery Academy
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1. Study Identification

Unique Protocol Identification Number
NCT03229005
Brief Title
Soft Tissue Width and Abutment Height Influence Peri-implant Bone Resorption
Acronym
i-RES
Official Title
Influence of Soft Tissue Width and Abutment Height on Peri-implant Bone Resorption: a Clinical and Radiographic Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
October 15, 2018 (Actual)
Study Completion Date
June 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Piezosurgery Academy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
Keywords
soft tissue; implant; abutment;

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1 thick-high
Arm Type
Active Comparator
Arm Description
group with thick tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation
Arm Title
A2 thick-low
Arm Type
Experimental
Arm Description
group with thick tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation
Arm Title
B1 thin-high
Arm Type
Active Comparator
Arm Description
group with thin tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation
Arm Title
B2 thin-low
Arm Type
Experimental
Arm Description
group with thin tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation
Intervention Type
Procedure
Intervention Name(s)
implant insertion
Intervention Description
during surgery soft tissues will be measured
Intervention Type
Procedure
Intervention Name(s)
operculectomy
Intervention Description
during second surgery soft tissues will be measured again
Intervention Type
Procedure
Intervention Name(s)
prosthetic rehabilitation
Intervention Description
after three months implants will be loaded with screw retained crown
Primary Outcome Measure Information:
Title
peri-implant bone resorption
Description
intraoral radiographs will be acquired and bone crest level will be compared with baseline
Time Frame
after 12 months
Title
implant survival
Description
clinical and radiographical examination
Time Frame
after 12 months
Secondary Outcome Measure Information:
Title
peri-implant bone resorption
Description
intraoral radiographs will be acquired
Time Frame
immediately after surgery (baseline)
Title
peri-implant bone resorption
Description
intraoral radiographs will be acquired
Time Frame
four months after surgery (at prosthesis delivery)
Title
peri-implant bone resorption
Description
intraoral radiographs will be acquired
Time Frame
six months after prosthetic loading
Title
peri-implant bone resorption
Description
intraoral radiographs will be acquired
Time Frame
24 months after prosthetic loading
Title
complications and/or adverse events
Description
clinical and radiographical examination
Time Frame
any time of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Stacchi, Dr.
Organizational Affiliation
Piezosurgery Academy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piezosurgery Academy
City
Parma
State/Province
PR
ZIP/Postal Code
43100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25678247
Citation
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.
Results Reference
background
PubMed Identifier
20605308
Citation
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.
Results Reference
background

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

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