Management of the Fresh Extraction Socket in the Aesthetic Area
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prosthetically driven implant placement.
- Who it may be relevant to
- Registry conditions: Tooth Extraction Status Nos, Dental Implant, Bone Augmentation, Soft Tissue Augmentation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Management of the Fresh Extraction Socket in the Aesthetic Area: Alveolar Ridge Preservation vs Immediate Implant Placement vs Delayed Implant Placement
Overview
After atraumatic tooth extraction and the assessment of the feasibility of immediate implant placement, patients will be randomly assigned to one of three treatment concepts: 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
The overall objective of this study will be to compare the three treatment modalities after tooth extraction (immediate implant placement, alveolar ridge preservation, spontaneous healing) in terms of:
* 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.
Interventions
- Procedure Prosthetically driven implant placement
Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan
Primary outcome measures
- Rate of adjunctive bone and soft tissue augmentation procedures need. [Time frame: during implant placement]
Secondary outcome measures (1)
- Peri-Implant Health [Time frame: 1, 3, 5 years post loading]
Eligibility criteria
Inclusion criteria
- single tooth extraction in the anterior region of the dentition (including premolars) to be extracted
- 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
- growing patients
- patients with autoimmune disease, uncontrolled diabetes or immunocompromised
- history of head and neck radiation for cancer treatment,
- pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Centro Specialistico Odontoiatrico (CSO) — Roma
Publications
- 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 Sup PMID 31215112
- 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. PMID 31050359
Identifiers
NCT: NCT04367766 · IIP/ARP/SH