Status:
COMPLETED
The Role of a New Prosthodontics Device in Hard and Soft Tissue Changes After Subcrestal Implant Placement
Lead Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Conditions:
Edentulous Alveolar Ridge
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The present randomized controlled trial aims to assess the influence of a new prosthodontics device (Gingival Former Abutment -GFA) on peri-implant bone loss and soft tissue changes and health after s...
Detailed Description
According to current literature, physiological bone loss around oral implants is expected after placement and load (1 mm during the first year and 0.2 mm each subsequent year). Different implant desig...
Eligibility Criteria
Inclusion
- Ability to comprehend and sign informed consent.
- Male and female subjects, aged 18-75 years, inclusive.
- Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives).
- Good oral health (no decay, periapical or periodontal lesions, PI and BOP \<25%).
- Patient with posterior single missing tooth:
- for at least 5 months,
- mandibular or maxillary,
- intercalated (distance between teeth more than 7.5 mm),
- at least 11 mm of height residual bone (from bone crest to maxillary sinus or inferior alveolar nerve),
- at least 5 mm of bone width (buccal - palatal/lingual).
- Availability for the 12-month duration of the study.
Exclusion
- Not willing to follow the agreed protocol.
- Presence of orthodontic appliances.
- Smokers more than 10 cigarettes per day.
- Chronic obstructive pulmonary disease and asthma.
- Tumors or significant pathology of the soft or hard tissues of the oral cavity.
- Current radiotherapy or chemotherapy.
- Pregnant or lactating women.
- Parafunctions like bruxism.
- Previous interventions to increase bone thickness in the implant area.
- Current or past assumption of medications that may influence surgical therapy and/or interfere with healing following surgical treatment.
- Systemic diseases that constitute a contraindication to surgical therapy and/or interfere with healing following surgical treatment.
Key Trial Info
Start Date :
June 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06182670
Start Date
June 6 2021
End Date
June 7 2023
Last Update
December 27 2023
Active Locations (1)
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1
Magda Mensi
Brescia, Lombardy, Italy, 25123