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

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: Procedure: implant insertion; Procedure: operculectomy; Procedure: prosthetic rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PR
    • Parma, PR, Italy, 43100
      • Piezosurgery Academy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A1 thick-high; group with thick tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation	Procedure: implant insertion; during surgery soft tissues will be measured; Procedure: operculectomy; during second surgery soft tissues will be measured again; Procedure: prosthetic rehabilitation; after three months implants will be loaded with screw retained crown
Experimental: A2 thick-low; group with thick tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation	Procedure: implant insertion; during surgery soft tissues will be measured; Procedure: operculectomy; during second surgery soft tissues will be measured again; Procedure: prosthetic rehabilitation; after three months implants will be loaded with screw retained crown
Active Comparator: B1 thin-high; group with thin tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation	Procedure: implant insertion; during surgery soft tissues will be measured; Procedure: operculectomy; during second surgery soft tissues will be measured again; Procedure: prosthetic rehabilitation; after three months implants will be loaded with screw retained crown
Experimental: B2 thin-low; group with thin tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation	Procedure: implant insertion; during surgery soft tissues will be measured; Procedure: operculectomy; during second surgery soft tissues will be measured again; Procedure: prosthetic rehabilitation; after three months implants will be loaded with screw retained crown

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
peri-implant bone resorption	intraoral radiographs will be acquired	immediately after surgery (baseline)
peri-implant bone resorption	intraoral radiographs will be acquired	four months after surgery (at prosthesis delivery)
peri-implant bone resorption	intraoral radiographs will be acquired	six months after prosthetic loading
peri-implant bone resorption	intraoral radiographs will be acquired	24 months after prosthetic loading
complications and/or adverse events	clinical and radiographical examination	any time of the study

Collaborators and Investigators

• Sponsor: International Piezosurgery Academy

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Actual): October 15, 2018
• Study Completion (Actual): June 15, 2019

Study Registration Dates

• First Submitted: July 22, 2017
• First Submitted That Met QC Criteria: July 22, 2017
• First Posted (Actual): July 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: soft tissue; implant; abutment
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: i-RES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No