Management of the Fresh Extraction Socket in the Aesthetic Area
NCT ID: NCT04367766
Last Updated: 2023-12-12
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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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-09-27
2026-08-31
Brief Summary
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1. Immediate Implant Placement and Immediate Provisionalization
2. Alveolar Ridge Preservation. After 4 months of healing an implant will be placed with simultaneous GBR and/or Soft Tissue Augmentation procedures, if needed.
3. Spontaneous Healing of the socket. After 4 months of healing, an implant will be placedwith simultaneous GBR and/or Soft Tissue Augmentation procedures, if needed.
In all groups, four months after implant placement, a prosthesis will be delivered. From this experimental period onward, patients will be scheduled for maintenance. Clinical, radiographic and volumetric assessment will be performed by clinicians not involved in the surgery and blind with respect to treatment assignment at 1, 3 and 5 years post loading.
Detailed Description
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* patient-related (morbidity) outcomes during surgical procedure and the first 2 weeks after the surgical procedure
* cost-effectiveness ratio (treatment time, number of surgeries, number of appointments and overall appointments time, need for bone and soft tissue augmentation, overall costs) at the time of prosthesis delivery
* volumetric bone and soft tissue changes of the site before treatment (prior to tooth extraction), 4 months after tooth extraction, 1, 3 and 5 years after final prosthesis.
* clinical, radiographic, aesthetic and patient-related (satisfaction) outcomes at the time of prosthesis delivery and 1, 3 and 5 years after final prosthesis.
* Implant Success and Survival at 1, 3 and 5 years after final prosthesis.
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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Immediate Implant Placement
prosthetically driven immediate implant placement (TLC implant, Straumann) with bone substitute (BioOss Collagen, Geistlich) filling the gap between the buccal socket wall and the implant surface and a collagen matrix (Fibrogide, Geistlich) positioning at the vestibular aspect to increase soft tissue volume, with immediate (non occlusal loading) prosthetic provisionalization.
Prosthetically driven implant placement
Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan
Alveolar Ridge Preservation (ARP) + Delayed Implant Placement:
ARP performed with bone substitute (BioOss Collagen, Geistlich) and a collagen matrix placed to seal the socket entrance (Mucograft Seal, Geistlich). After 4 months of healing a prosthetically driven implant (TLC implant, Straumann) will be placed with adjunctive GBR procedure with bone substitute (BioOss Collagen, Geistlich) and a collagen membrane (BioGide, Geistlich) if buccal bone will be \< 2 mm and soft tissue augmentation with a collagen matrix (Fibrogide, Geistlich) if soft tissue thickness will be \< 2mm
Prosthetically driven implant placement
Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan
Spontaneous Healing + Delayed Implant Placement
extraction socket will be left to heal spontaneously. After 4 months of healing a prosthetically driven implant (TLC implant, Straumann) will be placed with adjunctive GBR procedure with bone substitute (BioOss Collagen, Geistlich) and a collagen membrane (BioGide, Geistlich) if buccal bone will be \< 2 mm, and soft tissue augmentation with a collagen matrix (Fibrogide, Geistlich) if soft tissue thickness will be \< 2mm .
Prosthetically driven implant placement
Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan
Interventions
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Prosthetically driven implant placement
Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* smoking no more than 10 cigarettes/day,
* periodontal health (BoP \< 10%) and good plaque control (\< 20%)
* absence of symptomatic periapical radiolucencies, acute abscesses at the site of extraction,
* extraction sites with less than 30% loss of one or more walls
* adequate quantity and quality of native bone to achieve primary stability
Exclusion Criteria
* patients with autoimmune disease, uncontrolled diabetes or immunocompromised
* history of head and neck radiation for cancer treatment,
* pregnancy
18 Years
ALL
Yes
Sponsors
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Centro Specialistico Odontoiatrico, Rome
NETWORK
Responsible Party
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Marco Clementini
Research Fellow
Principal Investigators
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Marco Clementini, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
Centro Specialistico Odontoiatrico, Rome
Locations
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Centro Specialistico Odontoiatrico (CSO)
Roma, , Italy
Countries
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Central Contacts
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Facility Contacts
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Marco Clementini, DDS, PhD
Role: primary
References
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Tonetti MS, Jung RE, Avila-Ortiz G, Blanco J, Cosyn J, Fickl S, Figuero E, Goldstein M, Graziani F, Madianos P, Molina A, Nart J, Salvi GE, Sanz-Martin I, Thoma D, Van Assche N, Vignoletti F. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology. J Clin Periodontol. 2019 Jun;46 Suppl 21:183-194. doi: 10.1111/jcpe.13131.
Clementini M, Agostinelli A, Castelluzzo W, Cugnata F, Vignoletti F, De Sanctis M. The effect of immediate implant placement on alveolar ridge preservation compared to spontaneous healing after tooth extraction: Radiographic results of a randomized controlled clinical trial. J Clin Periodontol. 2019 Jul;46(7):776-786. doi: 10.1111/jcpe.13125. Epub 2019 May 31.
Other Identifiers
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IIP/ARP/SH
Identifier Type: -
Identifier Source: org_study_id