Harvard School of Dental Medicine
Boston, Massachusetts, 02115, United States
NCT Number: NCT05576922
The study aims at comparing two different approaches for the treatment of implant esthetic complications (peri-implant soft tissue dehiscences): autogenous connective tissue graft vs collagen matrix + recombinant human platelet derived growth factor-BB
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
The present randomized clinical trial aims at investigating two approaches (autogenous connective tissue graft vs collagen matrix + recombinant human platelet derived growth factor-BB) when performed in combination with the prosthetic-surgical approach for the treatment of 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
Indications for surgical intervention will be established based on patient's esthetic demands and peri-implant soft tissue phenotype.
Coronally advanced flap with an autogenous graft (CTG)
Coronally advanced flap with a graft substitute (collagen matrix and rhPDGF-BB)
Time frame: 6 and 12 months
Reduction 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) compared to baseline (expressed in millimeters)
Time frame: 6 and 12 months
Percentage of cases with complete resolution of the implant esthetic complication (expressed as a percentage)
Time frame: 6 and 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)
Harvard Medical School (HMS and HSDM)
Other
Xenogeneic Collagen Matrix Loaded With rhPDGF-BB vs Autogenous Connective Tissue Graft for the Treatment of Peri-implant Soft Tissue Dehiscences: A Randomized, Controlled, Clinical, Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT06917638
Implant Complication
Cairo, Egypt
View Trial DetailsNCT06554080
Dental Implant Failed, Implant Complication
Aldershot, Surrey, United Kingdom
View Trial DetailsNCT03524885
Bone Diseases, Bone Resorption
Valencia, Spain
View Trial DetailsNCT07636265
Implant Complication, Periimplant Bone Loss
Niğde, Niğde Province, Turkey (Türkiye)
View Trial Details