An interventional study of Immediate dental implant placement and Immediate dental implant placement with CTG in Implant, sponsored by Università Vita-Salute San Raffaele. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-17.
Sponsored by Università Vita-Salute San Raffaele · Not applicable, Interventional, and Treatment
A recent systematic review (Lee et al, 2016) reported that placement of a soft tissue graft concurrent with immediate implantation may contribute to the stability of gingival level and the augmentation of soft tissue contour. However, most included studies did not have a control group to directly demonstrate the benefit of an immediate implant combined with soft tissue graft (IMITG) compared to immediate implant alone.The objective of this randomized controlled clinical trial with a parallel design is to evaluate the influence of the connective tissue graft on the buccal bone alterations after tooth extraction and immediate implant placement by means of cone beam computer tomography (CBCT).
All participants will be selected on a consecutive basis, among individuals, above the age of 18 years, referred to Dental Clinic of the San Raffaele University, with a single failing tooth in the upper and lower jaw from second premolar to second premolar, candidates for a single implant restoration. After local anesthesia, a split-full-split thickness envelope flap, as described for the treatment of multiple gingival recessions by Zucchelli and de Sanctis (2000), will be elevated and the tooth will be extracted a-traumatically. The immediate implantation procedure will be carried out according to the manufacture protocol and 1mm of the transmucosal portion of the implant will be positioned under the buccal bone crest. In the group "Implant+CTG" a connective tissue graft (CTG), resulting from the extraoral de-epithelialization with the knife blade of a free gingival graft harvested from the palate, will be anchored at the anatomic papillae with 2 horizontal mattress sutures and positioned 1 mm coronal to the buccal bone crest and in the apical direction 2 mm above the buccal crest. Patients will be followed for 6 months after implant placement and 6 months after loading.
Università Vita-Salute San Raffaele is the lead sponsor of 84 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Immediate dental implant placement
Procedure: Immediate dental implant placement
Immediate dental implant placement with CTG.
Procedure: Immediate dental implant placement with CTG
Tooth will be extracted and a dental implant will be positioned at the same time.
Tooth will be extracted and a dental implant will be positioned at the same time with a connective tissue graft.
Volumetric buccal bone changes
Ratio scale - lower values represent a better outcome
Time frame: 6 months
Volumetric buccal soft tissue changes
Ratio scale - higher values represent a better outcome
Time frame: 6 months
Buccal soft tissue changes
Ratio scale - higher values represent a better outcome
Time frame: 6 months
Patient perception outcomes
Visual Analogic Scale - values from '0=no pain' to '10=worst pain imaginable'
Time frame: 1 week and 6 months
Plan to share: No
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Università Vita-Salute San Raffaele