Harvard School of Dental Medicine
Boston, Massachusetts, 02115, United States
Location status: Recruiting
NCT Number: NCT05729607
The study aims at comparing two different approaches for vertical soft tissue augmentation at implant sites exhibiting soft tissue dehiscences: autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative
Interested in participating?
Request Info18 year–99 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
Location status: Recruiting
The present randomized clinical trial aims at investigating two approaches (autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative) when performed for vertical soft tissue augmentation at sites with peri-implant soft tissue dehiscences. Clinical, volumetric, ultrasonographic, and patient-reported outcomes will be evaluated at different time points up to 1 year.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
are:
Vertical soft tissue augmentation with autogenous connective tissue graft (CTG)
Time frame: 12 months
Change of the depth of the Soft tissue dehiscence (vertical measurement of the complication, in relation to the level of the cemento-enamel junction of the contralateral homologous tooth) at 12 months compared to baseline (expressed in millimeters)
Time frame: 12 months
Percentage of cases with complete resolution of the implant esthetic complication (expressed as a percentage)
Time frame: 12 months
Percentage of coverage of the soft tissue dehiscence compared to baseline, measured with a formula considering final PSTD depth and initial PSTD depth (expressed as a percentage)
Time frame: 3, 6, and 12 months
Changes within the mucosal thickness measured with ultrasonography (expressed in mm)
Time frame: 3, 6, and 12 months
Changes within the buccal contour measured by superimposing digital impressions obtained with optical scanning (expressed in mm^3)
Time frame: 14 days after the surgery
Patient-reported pain after the surgical procedure (expressed with a 0-10 visual analogue scale [VAS])
Time frame: 12 months
Esthetic outcomes of the treatment assessed by a calibrated operator using the Implant soft tissue Dehiscence coverage Esthetic Score (IDES) (expressed using points, based on the IDES classification system from Zucchelli et al. 2021) The range is from 0 (worst outcome) to 10 (best outcome)
Contact information is provided by the study sponsor or research team.
Harvard Medical School (HMS and HSDM)
Other
Vertical Soft Tissue Augmentation With Dermal Matrix and Enamel Matrix Derivative vs Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences in the Esthetic Zone: A Randomized, Controlled, Clinical, Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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