Features of Peri-implant Soft Tissue Early Healing Around Different Abutment Materials
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Early healing of peri-implant soft tissues
Study Overview
Brief Summary
Soft tissue attachment to the implant surface serves as a biological seal preventing the development of inflammatory periimplant diseases (i.e. peri-implant mucositis and peri-implantitis).It occurs in the presence of a biomaterial during healing of the surgical wound that might be influence by this foreign body. Myofibroblasts represent key players in the physiological reconstruction of connective tissue after injury.
This work will focus on the role of myofibroblasts during the early phases of the healing process in peri-implant tissues around four different abutment materials.
Detailed Description
Dental implants are anchored in jawbone through a direct bonding between bone and the implant. Success and survival of an implant do, however, not depend solely on osseointegration. A soft tissue, which surrounds the transmucosal part of a dental implant, separates the peri-implant bone from the oral cavity. This soft tissue collar is called "peri-implant mucosa". The soft tissue attachment to the implant surface serves as a biological seal that prevents the development of inflammatory peri-implant diseases (i.e. peri-implant mucositis and peri-implantitis) Thus, the soft tissue seal around implants ensures healthy conditions and stable osseointegration and therefore also the long-term survival of an implant. While the soft tissue seal around teeth develops during tooth eruption, the peri-implant mucosa forms after the the surgical wound created to insert the implant. The wound healing phase may occur following the closure of a mucoperiosteal flap around the neck portion of an implant placed in a so-called one-stage procedure or after a second surgical intervention for abutment connections to an already installed dental implant (two-stage procedure).
It seems that the soft tissue adhesion is influenced by the properties (abutment material and micro-topography) of the implant components that are placed in contact with the soft tissues. Abutment material was found to influence bleeding on probing (BoP) at peri-implant soft tissues, as well.
Since wound healing occurs in the presence of a biomaterial (i.e. a foreign body) at a critical region, positive or negative interferences of wound healing events with this biomaterial and adaptation of the soft tissue to this biomaterial have to be taken into consideration. Biocompatibility, soft tissue adhesion, plaque retention, mechanical behavior and esthetics are listed among the criteria of material abutment selection. Titanium remains the most reliable material given its mechanical resistance, biocompatibility, modification of surface increasing cell adhesion and plaque retention. However, in the case of increased esthetics demands, particularly for thin biotype, zirconia and ceramics aluminum abutments give better results with comparable technical and biological outcomes to titanium abutments.
Polyetheretherketone (PEEK) is a strong thermoplastic material produced from polyetheretherketone resin. Because of its high mechanical strength and durability, good electrical characteristics and outstanding resistance to hydrolysis, PEEK has been used extensively in aerospace, automotive, chemical, electronics, petroleum, and food and beverage industries. Recently, a medical-grade PEEK was developed. Medical-grade PEEK has the same physical properties as PEEK; however, PEEK-OPTIMA™ is also biocompatible, has high chemical resistance and resists several different sterilization methods. It is noteworthy to mention that PEEK has an elastic modulus similar to that of the bone preventing marginal bone loss in case of occlusal overload. Due to the aforementioned properties, PEEK has been used as abutment material.
Morphology of the abutment deserves considerations, as well. Some physiological soft-tissue recession can be seen in time around implant restorations when a divergent emergence profile (the most common) is chosen next to the soft tissue. Recently it has been shown how some gingival coronal migration can be seen with the use of tapered emergence profile abutments. In fact, by using these tapered abutments or an implant design with a tapered shape at the neck implant level (transmucosal level), not only soft tissue migration but also hard tissue migration could be achieved over time.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Investigator)
Masking Description
double-blind
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age ≥ 18 years
- •Absence of Systemic Diseases / Disorders
- •Smoking ≤ 5 cigarettes per day
- •Periodontally healthy or treated
- •Full-mouth plaque score (FMPS) ≤ 15% at baseline
- •Full-mouth bleeding score (FMBS) ≤ 15% at baseline
- •Presence of edentulous space needing an all on four or all on six treatment with overdenture
- •Width of the keratinized gingiva ≥ 2 at the level of the crest
Exclusion Criteria
- •(I) • Pregnancy / lactation
- •Use of systemic antibiotics in the last 3 months
- •Use of systemic antibiotics as prophylaxis for endocarditis
- •A chronically treated patient (i.e. 2 weeks or longer) with medicines known to affect periodontal tissues (e.g. phenytoin, calcium antagonists, cyclosporine, warfarin and non-steroidal anti-inflammatory drugs) the last month before starting the study
- •Radiotherapy in the neck-head region
- •HIV, TB, hepatitis or other infectious diseases
- •Abuse with drugs or alcohol
- •Smoked cigarettes> 5 cigarettes per day
- •Untreated periodontitis
- •FMPS> 15% at baseline
- •FMBS> 15% at baseline
- •Implants with peri-implant history
- •Width of keratinized tissue over crest <2 mm
- •Need for bone reconstruction around implants to be inserted
Outcomes
Primary Outcomes
Early healing of peri-implant soft tissues
Time Frame: 24 hours
The early healing of soft peri-implant tissues will be interpreted through the activity of myofybroblasts
Secondary Outcomes
No secondary outcomes reported
Investigators
Andrea Pilloni MD DDS MS
MD DDS MS
University of Roma La Sapienza
