Massimo de Sanctis
Milan, Mi, 20132, Italy
NCT Number: NCT03784430
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).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Milan, Mi, 20132, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months
Ratio scale - lower values represent a better outcome
Time frame: 6 months
Ratio scale - higher values represent a better outcome
Time frame: 6 months
Ratio scale - higher values represent a better outcome
Time frame: 1 week and 6 months
Visual Analogic Scale - values from '0=no pain' to '10=worst pain imaginable'
Università Vita-Salute San Raffaele
Other
Soft and Hard Tissue Changes After Immediate Single-tooth Replacement With or Without a Submarginal Connective Tissue Graft
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.
NCT07697066
3D Printed Hybrid Resin, Healing
Tanta, El-Gharbia, Egypt
View Trial DetailsNCT04048239
Cochlear Hearing Loss, Ear Diseases
Amiens, France
View Trial DetailsNCT06808243
Dental, Implant
Minya, Egypt
View Trial DetailsNCT05921357
Implant, Mouth Diseases
Bolu, Turkey, Turkey (Türkiye)
View Trial Details