Management of the Fresh Extraction Socket in the Aesthetic Area
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentro Specialistico Odontoiatrico, Rome
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
growing patients
patients with autoimmune disease, uncontrolled diabetes or immunocompromised
history of head and neck radiation for cancer treatment,
pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Prosthetically driven implant placement
Procedure/SurgeryInsertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Immediate Implant PlacementActive comparator 1 intervention
Group B: Alveolar Ridge Preservation (ARP) + Delayed Implant Placement:Active comparator 1 intervention
Group C: Spontaneous Healing + Delayed Implant PlacementActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of adjunctive bone and soft tissue augmentation procedures need.
Number of participants with the need for adjunctive reconstructive hard tissue procedure during implant placement will be evaluated as a frequency (Yes/No) after a digital prosthetically driven implant placement. The need for soft tissue augmentation during implant placement will be evaluated as a frequency (Yes/No) by a blinded examiner in case of buccal soft tissue thickness \< 2mm assessed at 3mm apical to the full thickness flap margin with a caliber.
Time frame
during implant placementSecondary outcomes
1
Peri-Implant Health
Peri-implant health will be assessed as a frequency (Yes/No) at 1, 3, 5 years after prosthetic crown delivery by a blinded examiner in case of: absence of clinical signs of inflammation, absence of bleeding and/or suppuration on gentle probing, no increase in probing depth compared to previous examinations, absence of bone loss beyond crestal bone level changes resulting from initial bone remodeling
Time frame
1, 3, 5 years post loadingOther outcomes
1
Patient Reported Outcome Measurements
Patient's satisfaction with the final result will be assessed by means of a 100 mm VAS scale ranging from 0 (no satisfaction) to 100 (best possible satisfaction), recording patient's experience
Time frame
crown delivery, 1, 3, 5 years post loading2
Clinical parameters: Probing Depth (PD) and Recession (REC)
Probing Depth (PD) and Recession (REC) will be recorded in mm. with a periodontal probe (P-UNC 15, Hu Friedy) inserted with a standardised pressure into the peri-implant sulcus at 6 sites per implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual)
Time frame
crown delivery, 1, 3, 5 years post loading3
Clinical parameters: Bleeding on Probing (BoP)
Bleeding on Probing (BoP) will be recorded as presence/absence with a periodontal probe (P-UNC 15, Hu Friedy) inserted with a standardised pressure into the peri-implant sulcus at 6 sites per implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual)
Time frame
crown delivery, 1, 3, 5 years post loading4
Marginal Bone Level (MBL)
Marginal Bone Level (MBL) will be evaluated by a blinded examiner analysing an intra-oral radiograph on a computer software (Image J), as the distance in mm. between the smooth-rough interface and the mesial and distal bone level. The radiographs will be performed using a customized PVS bite block and an alignment device
Time frame
crown delivery, 1, 3, 5 years post loadingSponsors and contacts
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Source ClinicalTrials.gov