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NCT Number: NCT04367766

Management of the Fresh Extraction Socket in the Aesthetic Area

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.

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Key information

Conditions

Tooth Extraction Status Nos Bone Augmentation Dental Implant Soft Tissue Augmentation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Specialistico Odontoiatrico (CSO)

Roma, Italy

Location status: Recruiting

Location contact

Marco Clementini, DDS, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prosthetically driven implant placement

Procedure

Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan

Other names: Prosthetically driven implant installation

Primary outcomes

  1. Rate of adjunctive bone and soft tissue augmentation procedures need.

    Time frame: during implant placement

    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.

Secondary outcomes

  1. Peri-Implant Health

    Time frame: 1, 3, 5 years post loading

    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

Other outcomes

  1. Patient Reported Outcome Measurements

    Time frame: crown delivery, 1, 3, 5 years post loading

    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

  2. Clinical parameters: Probing Depth (PD) and Recession (REC)

    Time frame: crown delivery, 1, 3, 5 years post loading

    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)

  3. Clinical parameters: Bleeding on Probing (BoP)

    Time frame: crown delivery, 1, 3, 5 years post loading

    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)

  4. Marginal Bone Level (MBL)

    Time frame: crown delivery, 1, 3, 5 years post loading

    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

  5. Aesthetic

    Time frame: crown delivery, 1, 3, 5 years post loading

    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.

  6. Volumetric bone and soft tissue changes

    Time frame: before tooth extraction, 4 months after tooth extraction, at prosthetic crown delivery and 1, 3 and 5 year after crown delivery.

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Clementini, DDS, PhD

CONTACT

[email protected]

00393388378866

Sponsors and collaborators

Lead sponsor

Centro Specialistico Odontoiatrico, Rome

Network

Registry information

Official study title

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

Acronym: IIP/ARP/SH

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Apr 29, 2020
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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