The Role of a New Prosthodontics Device in Hard and Soft Tissue Changes After Subcrestal Implant Placement
NCT ID: NCT06182670
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2021-06-06
2023-06-07
Brief Summary
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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.
Detailed Description
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The GFA was created to limit both the loss of peri-implant crestal bone and the extension of the transmucosal tunnel. The GFA follows the "one abutment one time" concept, which is believed to limit disturbances of the peri-implant hard and soft tissues healing due to the removal of the traditional healing abutments during prosthetic load procedures. Our objective is to validate or deny this claim.
The study is a monocentric, pragmatic, single-blinded, randomized clinical trial (RCT) of parallel design. The trial will have a one-year duration, with data collection at the surgical phase, at implant load and 6 and 12 months after load. The primary outcome will be radiographical MBL (marginal bone level) changes around the implant. Secondary outcomes will be the assessment of the peri-implant soft tissues.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Subcrestal implant and gingival former abutment (GFA)
The subjects receive a subcrestal implant and a prosthodontic device (GFA) immediately during the surgery. The GFA will not be removed upon prosthetic load. It will be an integral part of the prosthetic finalization.
Gingival Former Abutment
GFA is positioned on the sub-crestal implant during the surgery and it is no longer removed. This follows the "one abutment one time" concept and should prevent bone loss and transmucosal tunnel.
Subcrestal Implant
Placement of the endosseous sub-crestal dental implant through dedicated drills with 35 Newton insertion torque. It is positioned 2 mm under the crestal bone.
Prosthetic Crown
A zirconia prosthetic crown finalizes the implant rehabilitation.
Crestal implant and traditional abutment
The subjects receive a crestal implant and healing abutment. The healing abutment will be replaced by a definitive abutment to the prosthetic load.
Healing Abutment
A healing abutment is positioned on crestal implant during surgery. It is removed at prosthetic finalization.
Prosthetic Crown
A zirconia prosthetic crown finalizes the implant rehabilitation.
Crestal Implant
Placement of the endosseous crestal implant through dedicated drills with 35 Newton insertion torque at level of the alveolar bone.
Interventions
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Gingival Former Abutment
GFA is positioned on the sub-crestal implant during the surgery and it is no longer removed. This follows the "one abutment one time" concept and should prevent bone loss and transmucosal tunnel.
Subcrestal Implant
Placement of the endosseous sub-crestal dental implant through dedicated drills with 35 Newton insertion torque. It is positioned 2 mm under the crestal bone.
Healing Abutment
A healing abutment is positioned on crestal implant during surgery. It is removed at prosthetic finalization.
Prosthetic Crown
A zirconia prosthetic crown finalizes the implant rehabilitation.
Crestal Implant
Placement of the endosseous crestal implant through dedicated drills with 35 Newton insertion torque at level of the alveolar bone.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
OTHER
Responsible Party
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Magda Mensi
Principal Investigator
Principal Investigators
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Magda Mensi
Role: PRINCIPAL_INVESTIGATOR
ASST Spedali Civili di Brescia
Locations
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Magda Mensi
Brescia, Lombardy, Italy
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NABUT NP 4078
Identifier Type: -
Identifier Source: org_study_id