Management of the Fresh Extraction Socket in the Aesthetic Area (IIP/ARP/SH)

December 6, 2023 updated by: Marco Clementini, Centro Specialistico Odontoiatrico, Rome

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Roma, Italy
        • Recruiting
        • Centro Specialistico Odontoiatrico (CSO)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immediate Implant Placement
prosthetically driven immediate implant placement (TLC implant, Straumann) with bone substitute (BioOss Collagen, Geistlich) filling the gap between the buccal socket wall and the implant surface and a collagen matrix (Fibrogide, Geistlich) positioning at the vestibular aspect to increase soft tissue volume, with immediate (non occlusal loading) prosthetic provisionalization.
Procedure: Prosthetically driven implant placement
Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan
Other Names:
  • Prosthetically driven implant installation
Active Comparator: Alveolar Ridge Preservation (ARP) + Delayed Implant Placement:
ARP performed with bone substitute (BioOss Collagen, Geistlich) and a collagen matrix placed to seal the socket entrance (Mucograft Seal, Geistlich). After 4 months of healing a prosthetically driven implant (TLC implant, Straumann) will be placed with adjunctive GBR procedure with bone substitute (BioOss Collagen, Geistlich) and a collagen membrane (BioGide, Geistlich) if buccal bone will be < 2 mm and soft tissue augmentation with a collagen matrix (Fibrogide, Geistlich) if soft tissue thickness will be < 2mm
Procedure: Prosthetically driven implant placement
Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan
Other Names:
  • Prosthetically driven implant installation
Active Comparator: Spontaneous Healing + Delayed Implant Placement
extraction socket will be left to heal spontaneously. After 4 months of healing a prosthetically driven implant (TLC implant, Straumann) will be placed with adjunctive GBR procedure with bone substitute (BioOss Collagen, Geistlich) and a collagen membrane (BioGide, Geistlich) if buccal bone will be < 2 mm, and soft tissue augmentation with a collagen matrix (Fibrogide, Geistlich) if soft tissue thickness will be < 2mm .
Procedure: Prosthetically driven implant placement
Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan
Other Names:
  • Prosthetically driven implant installation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during implant placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1, 3, 5 years post loading

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
crown delivery, 1, 3, 5 years post loading
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)
crown delivery, 1, 3, 5 years post loading
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)
crown delivery, 1, 3, 5 years post loading
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
crown delivery, 1, 3, 5 years post loading
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.
crown delivery, 1, 3, 5 years post loading
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)
before tooth extraction, 4 months after tooth extraction, at prosthetic crown delivery and 1, 3 and 5 year after crown delivery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Specialistico Odontoiatrico, Rome

Investigators

  • Principal Investigator: Marco Clementini, DDS, PhD, Centro Specialistico Odontoiatrico, Rome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

April 25, 2020

First Submitted That Met QC Criteria

April 28, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIP/ARP/SH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results will be presented in open access publication in international peer-reviewed journal

IPD Sharing Time Frame

From the publication acceptance by the international peer-reviewed journal

IPD Sharing Access Criteria

Open access publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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