Alveolar Ridge Preservation Clinical Trial
Official title:
The Impact of Immediate Implant Placement on Alveolar Ridge Preservation Techniques: a Clinical, Volumetric and Radiological Randomized Controlled Clinical Trial.
NCT number | NCT03422458 |
Other study ID # | 14-034 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2016 |
Est. completion date | April 11, 2018 |
Verified date | April 2019 |
Source | Università Vita-Salute San Raffaele |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 11, 2018 |
Est. primary completion date | April 11, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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%). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Università Vita-Salute San Raffaele | Milano | MI |
Lead Sponsor | Collaborator |
---|---|
Università Vita-Salute San Raffaele | Osteology Foundation |
Italy,
Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hämmerle 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hard tissue volumetric changes | Bone volumes changes at tooth extraction site | 4 months | |
Primary | Soft tissue volumetric changes | Soft tissue volumes changes at tooth extraction site | 4 months | |
Secondary | Keratinezed tissue (KT) | KT width changes at tooth extraction site | 4 months |
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