Clinical trial NCT04367766: Management of the Fresh Extraction Socket in the Aesthetic Area
Official title: Management of the Fresh Extraction Socket in the Aesthetic Area: Alveolar Ridge Preservation vs Immediate Implant Placement vs Delayed Implant Placement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tooth Extraction Status Nos
Dental Implant
Bone Augmentation
Soft Tissue Augmentation
Keywords: Immediate implant placement
alveolar ridge preservation
delayed implant placement
PROMs
implant health
volumetric analysis
tissue augmentation
Lead sponsor: Centro Specialistico Odontoiatrico, Rome
Sponsor class: NETWORK
First posted: 2020-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Rate of adjunctive bone and soft tissue augmentation procedures need.
timeFrame: during implant placement
Secondary outcomes:
measure: Peri-Implant Health
timeFrame: 1, 3, 5 years post loading
Other outcomes:
measure: Patient Reported Outcome Measurements
timeFrame: crown delivery, 1, 3, 5 years post loading
measure: Clinical parameters: Probing Depth (PD) and Recession (REC)
timeFrame: crown delivery, 1, 3, 5 years post loading
measure: Clinical parameters: Bleeding on Probing (BoP)
timeFrame: crown delivery, 1, 3, 5 years post loading
measure: Marginal Bone Level (MBL)
timeFrame: crown delivery, 1, 3, 5 years post loading
measure: Aesthetic
timeFrame: crown delivery, 1, 3, 5 years post loading
measure: Volumetric bone and soft tissue changes
timeFrame: before tooth extraction, 4 months after tooth extraction, at prosthetic crown delivery and 1, 3 and 5 year after crown delivery.
Locations:
city: Roma
country: Italy
facility: Centro Specialistico Odontoiatrico (CSO)
Study officials:
affiliation: Centro Specialistico Odontoiatrico, Rome
name: Marco Clementini, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.