Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Influence of Thickness of the Peri-implant Soft Tissue on Marginal Bone Remodeling (STR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03077880
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
University of Trieste
Information provided by (Responsible Party):
Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy

Brief Summary:
The aim of this observational study is the evaluation of marginal bone remodeling after surgical implant placement, correlating the gingival thickness with the bone resorption rate.

Condition or disease Intervention/treatment
Alveolar Bone Loss Procedure: intra-operatory measurement during implant placement

Detailed Description:

The present study was designed as a multicenter prospective clinical trial. Five clinical centers will treat patients through the placement of a single dental implant. The fixtures will be prosthetic loaded three months after placement and will be acquired periapical radiographs at each timepoint (base-two months-three-months-6 months-12 months). For every inserted implants the experimental parameters will be collected for the following 2 years.

Surgical procedure. All patients will receive antibiotic prophylaxis with 2 g of amoxicillin one hour before surgery. Crestal incision is performed under local anesthesia with articaine 4% with epinephrine, taking care to preserve the keratinized tissue. With the help of a periosteal elevator, it will be set up carefully buccal flap total thickness, and the vertical thickness of the soft tissue will be measured with a labeled probe every 1.0 mm. If the vertical thickness of the soft tissue will be 2 mm or less, it will be considered thin. If mucosal thickness will be greater than 2 mm, it will be considered thick. After measurement, the lingual flap will be raised to full-thickness, and will be prepared the site for implant placement. The implant site will be at least 1.5 mm from the tooth / teeth adjacent, and must be surrounded by at least 1 mm of bone is buccal to lingual. With a platform switching facility a millimeter will be placed below the level of the bone crest with a one-stage approach as per the manufacturer's recommendations. After insertion, it will be screwed a healing abutment, and the flaps will be sutured without tension with interrupted sutures 4/0. Patients of both groups will be instructed to disinfect the site through a rinse twice a day for a week for 1 minute with 0.12% chlorhexidine digluconate. Patients will be advised to avoid chewing on the operated site and cleaning the healing abutments with an ultra soft toothbrush. After 2 months of healing, it will be evaluated clinical stability and the radiographic appearance of the plants. All plants will be rehabilitated by the prosthetist with single screwed restorations. After the prosthetic treatment, patients will receive oral hygiene instruction and will be monitored through calls to ensure periodontal health (Bleeding on Probing <20% and Plaque Index <25%) throughout the study period.

Radiographic evaluation Intraoral radiographs will be captured in high-resolution mode with a film, customized support from a jig polyvinylsiloxane, using the technique of parallel rays. Intraoral radiographs will be acquired after implant placement (baseline-assessment of inclusion fairness), after 2 months of healing (osseointegration rating), after insertion of the crown (3 months-adaptation assessment of the restoration prosthetic), after 6 months (early loading of evaluation) and after a year of recovery (of the medium-term load rating). The number of intraoral radiographs will be the same which normally is carried out in the course of an implant-prosthetic rehabilitation. The images will be obtained in such a way that the implant-abutment interface is clearly visible. Measurements of bone level will be performed by a blinded central reader using a dedicated program at 20 times magnification. Before the calculation of the crestal bone changes, the RVG images will be calibrated with the implant diameter. bone loss will be calculated by comparing the radiographs at baseline with the radiographs obtained during follow-up visits. The system board and the first contact radiographic bone-implant will be selected as reference points to calculate bone loss. The average of the mesial and distal measurements will be recorded for each implant.


Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence Of Thickness Of the Peri-implant Soft Tissue On Marginal Bone Remodeling Around Bone Level Implant: A Multicenter Observational Clinical Study
Actual Study Start Date : January 15, 2017
Actual Primary Completion Date : July 15, 2018
Actual Study Completion Date : September 15, 2018

Group/Cohort Intervention/treatment
thin soft tissue
full thickness thin mucosal soft tissue at the periodontal probe measured intra-operatory measurement during implant placement
Procedure: intra-operatory measurement during implant placement
mucoperiosteal flap, soft tissue thickness measurement, implant insertion

thick soft tissue
full thickness thick mucosal soft tissue at the periodontal probe measured intra-operatory measurement during implant placement
Procedure: intra-operatory measurement during implant placement
mucoperiosteal flap, soft tissue thickness measurement, implant insertion




Primary Outcome Measures :
  1. peri-implant bone resorption [ Time Frame: from baseline to twelve months ]
    radiological assessment of change in the peri-implant bone crest



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
patients referred to the centers
Criteria

Inclusion Criteria:

  1. indications for intervention of implant placement in posterior mandible (premolar / molar region) based on a careful diagnosis and treatment plan;
  2. presence of a residual osseous crest with a minimum of 7 mm surgical height, and thickness of at least 6 mm at the level of the programmed implant site;
  3. the bone crest must be healed (at least 6 months after the loss / extraction of the element corresponding tooth);
  4. absence of regenerated bone;
  5. plaque index of less than 25% and bleeding index lower than 20%;
  6. bucco-lingual width of the attached gingiva ≥ 4 mm;
  7. insertion torque plant inserito≥35 N / cm;
  8. patient age> 18 years;
  9. patients should be able to examine and understand the study protocol;
  10. informed consent.

Exclusion Criteria:

  1. acute myocardial infarction in the last two months;
  2. blood coagulation disorders not compensated;
  3. uncontrolled diabetes (HbA1c> 7.5%);
  4. radiation therapy of the district head / neck in the last 24 months;
  5. immunocompromised patients (HIV infection or chemotherapy) within the last 5 years);
  6. present or past treatment with intravenous bisphosphonates;
  7. psychological or psychiatric diseases;
  8. alcohol or drug abuse;
  9. Smoking of local exclusion criteria are the diagnosis of periodontal disease acute or chronic, a previous history of periodontal disease, the presence of regenerated bone, lingual bucco- size of keratinized tissue <4 mm, insertion torque less than 35 N / cm.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077880


Locations
Layout table for location information
Italy
Piezosurgery Academy
Parma, Italy, 43100
Sponsors and Collaborators
International Piezosurgery Academy
University of Trieste
Investigators
Layout table for investigator information
Principal Investigator: Claudio Stacchi, Dr. Piezosurgery Academy

Publications:
Layout table for additonal information
Responsible Party: Mr. Claudio Stacchi, DDS, MSc, President of Piezosurgery Academy, International Piezosurgery Academy
ClinicalTrials.gov Identifier: NCT03077880     History of Changes
Other Study ID Numbers: STR
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy:
implant insertion
bone resorption
soft tissue
Additional relevant MeSH terms:
Layout table for MeSH terms
Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases