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

NCT03229005 | Completed

• 1 other identifier: i-RES
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Loss

Keywords

soft tissue; implant; abutment;

Outcome Measures

Primary Outcomes (2)

• peri-implant bone resorption

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

  after 12 months

• implant survival

  clinical and radiographical examination

  after 12 months

Secondary Outcomes (5)

• peri-implant bone resorption

  immediately after surgery (baseline)

• peri-implant bone resorption

  four months after surgery (at prosthesis delivery)

• peri-implant bone resorption

  six months after prosthetic loading

• peri-implant bone resorption

  24 months after prosthetic loading

• complications and/or adverse events

  any time of the study

Study Arms (4)

A1 thick-high

ACTIVE COMPARATOR

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

Procedure: implant insertion; Procedure: operculectomy; Procedure: prosthetic rehabilitation

A2 thick-low

EXPERIMENTAL

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

Procedure: implant insertion; Procedure: operculectomy; Procedure: prosthetic rehabilitation

B1 thin-high

ACTIVE COMPARATOR

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

Procedure: implant insertion; Procedure: operculectomy; Procedure: prosthetic rehabilitation

B2 thin-low

EXPERIMENTAL

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

Procedure: implant insertion; Procedure: operculectomy; Procedure: prosthetic rehabilitation

Interventions

implant insertion PROCEDURE

during surgery soft tissues will be measured

A1 thick-high; A2 thick-low; B1 thin-high; B2 thin-low

operculectomy PROCEDURE

during second surgery soft tissues will be measured again

A1 thick-high; A2 thick-low; B1 thin-high; B2 thin-low

prosthetic rehabilitation PROCEDURE

after three months implants will be loaded with screw retained crown

A1 thick-high; A2 thick-low; B1 thin-high; B2 thin-low

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Piezosurgery Academy: lead

Study Sites (1)

Piezosurgery Academy

Parma, PR, 43100, Italy

Location

Related Publications (2)

• 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.

  PMID: 25678247 BACKGROUND

• 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.

  PMID: 20605308 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Claudio Stacchi, Dr.

  Piezosurgery Academy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of the Academy

Study Record Dates

• First Submitted: July 22, 2017
• First Posted: July 25, 2017
• Study Start: May 15, 2017
• Primary Completion: October 15, 2018
• Study Completion: June 15, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)