The Impact of Immediate Implant Placement on Alveolar Ridge Preservation Techniques

NCT03422458 | Completed DMC

• 1 other identifier: 14-034
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

It is well known that following the loss of a single tooth, severe hard- and soft-tissue alterations may take place within the affected site, resulting in a subsequent reduction of both vertical and horizontal ridge dimensions, often not allowing neither appropiate pontic fabrication nor correct placement of endosseous implants. Over the past 20 years, various surgical procedures, grouped under the term of "alveolar ridge preservation" (ARP), have been introduced, aiming to maintain the existing soft and hard tissue envelope as well as a stable ridge volume, simplifying subsequent treatment procedures and optimizing functional and esthetic outcomes. They have been widely tested in controlled and not controlled clinical studies with various materials and approaches, and a number of recently published systematic reviews on this topic have confirmed the efficacy of ARP in preventing post-extraction dimensional changes of alveolar ridges. After these procedures a minimum of four to six months must be awaited before implant insertion can be performed, bringing the patient compromised comfort, function and aesthetics and needing of a second surgical procedure for the implant placement. Dental implant insertion at the time of tooth extraction (type I or immediate placement) reduced the number of dental appointments, of surgeries required and the overall treatment time. Nevertheless this surgical protocol does not provide predictable outcomes, since it may contribute towards a more pronounced bone resorption during healing. Different anatomical factors, as the thickness of the buccal bone wall and the dimension of the horizontal gap, may influence the dimensional changes of the alveolar crest following immediate implant placement. Such morphological changes could lead to negative esthetic complications, such as marginal soft tissues recessions, especially when affecting the buccal side of maxillary sites in patients with a high smile line. It is unknown if immediate implant placement plus grafting materials and/or barrier membranes could influence post-extraction dimensional changes of alveolar ridges. No consensus exists on the need for bone augmentation simultaneously with immediate implant placement. Furthermore, no human study has yet compared dimensional changes of both hard and soft tissues after two different treatments: an alveolar ridge preservation technique for a subsequent implant placement, and an alveolar ridge preservation technique with an immediate implant placement.

Conditions

Post-Extraction Socket; Immediate Implant Placement; Alveolar Ridge Preservation

Outcome Measures

Primary Outcomes (2)

• Hard tissue volumetric changes

  Bone volumes changes at tooth extraction site

  4 months

• Soft tissue volumetric changes

  Soft tissue volumes changes at tooth extraction site

  4 months

Secondary Outcomes (1)

• Keratinezed tissue (KT)

  4 months

Study Arms (3)

natural healing

NO INTERVENTION

no treatment and the coagulum within the socket is left open for spontaneous healing

Alveolar Ridge Preservation

EXPERIMENTAL

A bone substitute material (BioOss Collagen) is placed within the bony envelope at least to the level of the palatal/ lingual bone plate. Subsequently, the soft tissue borders of the alveole is de-epithelialized using a diamond drill under copious irrigation with water. A collagen matrix (Mucograft Seal) is adapted to the soft tissue borders again using single interrupted sutures.

Device: Alveolar Ridge Preservation

Immediate Implant + Alveolar Ridge Preservation

EXPERIMENTAL

An immediate implant (Winsix) placement is performed. After implant insertion, a bone substitute material (BioOss Collagen) is placed in the gap occurred between the implant surface and the hard tissue walls of the extraction socket at least to the level of the palatal/ lingual bone plate. Subsequently, the soft tissue borders of the alveole is de-epithelialized using a diamond drill under copious irrigation with water. A collagen matrix (Mugograft Seal) is adapted to the soft tissue borders again using single interrupted sutures.

Device: Alveolar Ridge Preservation

Interventions

Alveolar Ridge Preservation DEVICE

Insertion of a bone substitute material (BioOss Collagen) within the bony envelope at least to the level of the palatal/ lingual bone plate. Adaptation of a collagen matrix (Mucograft Seal) to the soft tissue borders.

Alveolar Ridge Preservation; Immediate Implant + Alveolar Ridge Preservation

Eligibility Criteria

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

You may qualify if:

• Adult patients (\> 18 years old) requiring extraction (for caries, fracture, periodontitis, prosthetic reasons) and subsequent moderately rough implant-supported single crown of one upper or lower asymptomatic front tooth or premolar
• Systemically healthy patients not smoking more than 10 cigarettes/day.
• Oral healty patients with adequate oral hygiene (bleeding on probing \< 30%; Plaque index\< 30%).

You may not qualify if:

• Patients smoking more than 10 cigarettes per day.
• Patients with oral mucosa diseases
• Patients with insulin-dependent diabetes.
• Patients with a history of malignancy, radiotherapy, or chemotherapy for malignancy.
• Patient pregnant or intended to be pregnant or nursing
• Patients taking medications or having treatments with an effect on mucosal healing in general (e.g. steroids, large doses of antiinflammatory drugs).
• Patients with a disease affecting connective tissue metabolism.
• Patients allergic to collagen.

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead
• Osteology Foundation: collaborator

Study Sites (1)

Università Vita-Salute San Raffaele

Milan, MI, 20132, Italy

Location

Related Publications (3)

• Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.

  PMID: 23163915 BACKGROUND

• Clementini M, Castelluzzo W, Ciaravino V, Agostinelli A, Vignoletti F, Ambrosi A, De Sanctis M. The effect of immediate implant placement on alveolar ridge preservation compared to spontaneous healing after tooth extraction: Soft tissue findings from a randomized controlled clinical trial. J Clin Periodontol. 2020 Dec;47(12):1536-1546. doi: 10.1111/jcpe.13369. Epub 2020 Oct 21.

  PMID: 32956551 DERIVED

• 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 DERIVED

Study Design

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

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: February 5, 2018
• Study Start: January 1, 2016
• Primary Completion: April 11, 2018
• Study Completion: April 11, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)