The Role of a New Prosthodontics Device in Hard and Soft Tissue Changes After Subcrestal Implant … (NCT06182670) | Clinical Trial Compass
CompletedNot Applicable
The Role of a New Prosthodontics Device in Hard and Soft Tissue Changes After Subcrestal Implant Placement
Italy40 participantsStarted 2021-06-06
Plain-language 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 subcrestal oral implant placement.
The participants will be divided in two groups and receive either crestal implant placement and traditional healing abutment or subcrestal implant placement and GFA.
Clinical and radiographic examination will be performed at implant placement surgery, prosthetic load, 6 and 12 months follow-up.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 contraindi…
What they're measuring
1
Change in Marginal Bone Level (MBL)
Timeframe: Surgery, 3, 9 and 15 months
Trial details
NCT IDNCT06182670
SponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia