Management of the Fresh Extraction Socket in the Aesthetic Area

NCT04367766 | Recruiting DMC

• 1 other identifier: IIP/ARP/SH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Immediate Implant Placement and Immediate Provisionalization
2. 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. 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.

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

Outcome Measures

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.

  during implant placement

Secondary Outcomes (1)

• Peri-Implant Health

  1, 3, 5 years post loading

Other Outcomes (6)

• Patient Reported Outcome Measurements

  crown delivery, 1, 3, 5 years post loading

• Clinical parameters: Probing Depth (PD) and Recession (REC)

  crown delivery, 1, 3, 5 years post loading

• Clinical parameters: Bleeding on Probing (BoP)

  crown delivery, 1, 3, 5 years post loading

Study Arms (3)

Immediate Implant Placement

ACTIVE COMPARATOR

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

Alveolar Ridge Preservation (ARP) + Delayed Implant Placement:

ACTIVE COMPARATOR

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

Spontaneous Healing + Delayed Implant Placement

ACTIVE COMPARATOR

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

Interventions

Prosthetically driven implant placement PROCEDURE

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

Also known as: Prosthetically driven implant installation

Alveolar Ridge Preservation (ARP) + Delayed Implant Placement:; Immediate Implant Placement; Spontaneous Healing + Delayed Implant Placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• growing patients
• patients with autoimmune disease, uncontrolled diabetes or immunocompromised
• history of head and neck radiation for cancer treatment,
• pregnancy

Sponsors & Collaborators

• Centro Specialistico Odontoiatrico, Rome: lead

Study Sites (1)

Centro Specialistico Odontoiatrico (CSO)

Roma, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 31215112 BACKGROUND

• 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.

  PMID: 31050359 BACKGROUND

Study Officials

• Marco Clementini, DDS, PhD

  Centro Specialistico Odontoiatrico, Rome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Clementini, DDS, PhD

CONTACT

00393388378866; mclementini@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: April 29, 2020
• Study Start: September 27, 2023
• Primary Completion: April 1, 2024
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From the publication acceptance by the international peer-reviewed journal
• Access Criteria: Open access publication

Locations

IT (1)