Management of the Fresh Extraction Socket in the Aesthetic Area

Dental Implant Clinical Trial

— IIP/ARP/SH  

Official title:

Management of the Fresh Extraction Socket in the Aesthetic Area: Alveolar Ridge Preservation vs Immediate Implant Placement vs Delayed Implant Placement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04367766
• Other study ID #: IIP/ARP/SH
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2023
• Est. completion date: August 2026

Study information

• Verified date: December 2023
• Source: Centro Specialistico Odontoiatrico, Rome
• Contact: Marco Clementini, DDS, PhD
• Phone: 00393388378866
• Email: mclementini[@]me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2026
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Augmentation
• Dental Implant
• Soft Tissue Augmentation
• Tooth Extraction Status Nos

Intervention

Procedure:
• Prosthetically driven implant placement
Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan

Locations

Country	Name	City	State
Italy	Centro Specialistico Odontoiatrico (CSO)	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Centro Specialistico Odontoiatrico, Rome

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	crown delivery, 1, 3, 5 years post loading
Other	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)	crown delivery, 1, 3, 5 years post loading
Other	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)	crown delivery, 1, 3, 5 years post loading
Other	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	crown delivery, 1, 3, 5 years post loading
Other	Aesthetic	Aesthetic will be evaluated by a blinded examiner analysing pictures using the modified pink and white aesthetic score (PES/WES system, Belser et al. 2009) and giving a score from 0 to 20.	crown delivery, 1, 3, 5 years post loading
Other	Volumetric bone and soft tissue changes	Volumetric bone change will be assessed by a blinded examiner analysing on a computer software (SMOP) DICOM files from cone-beam computed tomography (CBCT) scan. Contour soft tissue change and buccal soft tissue volume will be assessed by a blinded examiner analysing on a computer software (SMOP) STL files from digital impression. Dynamic Soft tissue healing will be assessed by a blinded examiner analysing superimposition on a computer software (SMOP) of DICOM files (from CBCT) and STL files (from digital impression)	before tooth extraction, 4 months after tooth extraction, at prosthetic crown delivery and 1, 3 and 5 year after crown delivery.
Primary	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.	during implant placement
Secondary	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	1, 3, 5 years post loading