Araraquara Dental School at the São Paulo State University
Araraquara, São Paulo, 14801-903, Brazil
NCT Number: NCT02922075
This study evaluates the impact of soft tissue grafts on soft tissue recession following immediate implant, provisional and bone graft placement in compromised sockets. One third of the patients received a collagen matrix (CM group), another third received a connective tissue graft removed from the palate (CTG group) and the final third did not receive any soft tissue graft (CTL group).
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Phase 4
Araraquara, São Paulo, 14801-903, Brazil
Preventing soft tissue recession following flapless immediate implant and provisional placement (IIPP) in sockets with facial bone dehiscences is a challenge, mainly in esthetic areas. This study evaluated the impact of soft tissue grafts on peri-implant alterations after 1-year follow-up. Twenty-four patients with one single failing maxillary incisor presenting facial bone dehiscence and receiving IIPP were randomly divided in three groups (n= 8 in each group): Control (CTL); Collagen Matrix (CM); Connective tissue graft (CTG). In addition to soft tissue grafts, all groups were treated with collagen membrane and deproteinized bovine bone mineral containing 10% of porcine collagen. Clinical, photographic and tomographic analyses were performed at baseline, 6 and 12 months after surgery to evaluate tissue alterations.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A 1.5 mm thick soft tissue graft removed from the palate with determined dimensions. The recipient site was prepared by performing laterally a delicate elevation of the facial tissue avoiding the mesial and distal papilla. The soft tissue graft length was equal to the horizontal distance between the two papillas and its length was set at 6 mm. Soft tissue grafts were placed at the level of the gingival margin and stabilized with simple interrupted sutures.
Other names: autogenous subepithelial connective tissue graft
A 15x20 mm collagen matrix trimmed according to determined dimensions. The recipient site was prepared by performing laterally a delicate elevation of the facial tissue avoiding the mesial and distal papilla. The soft tissue graft length was equal to the horizontal distance between the two papillas and its length was set at 6 mm. Soft tissue grafts were placed at the level of the gingival margin and stabilized with simple interrupted sutures.
Other names: heterogenous graft
A conical implant with a morse-taper connection with moderate roughness implant surface was properly installed in the ideal tridimensional position with its platform placed 4 mm below the facial gingival margin. After tooth extraction and dental implant installation with a torque > 32 Ncm patients were randomized into three groups (8 patients per group): 1- No soft tissue graft, Control group (CTL); 2- Collagen Matrix group (CM); 3- Connective tissue graft group (CTG).
Compromised tooth was gently removed and the socket was debrided thoroughly, cleansed and inspected. The socket's palatal and apical bone was sequentially drilled. All surgeries were performed by the same surgeon and were individually planned according to the clinical and tomographic evaluation. Implant diameter was set as 3.5 mm and its length was selected according to the quantity of bone available apically to the fresh alveolar socket.
A titanium abutment was installed in the dental implant with manual torque and a prefabricated tooth shell was relined with resin material to fabricate cement or screw retained interim restoration. All interim restorations were installed in infra-occlusion matching the adjacent teeth color and form, with light proximal contacts and presented a subgingival concave contour.
All sites received a non-cross linked collagen membrane and deproteinized bovine bone mineral containing 10% of porcine collagen.
Other names: Bio-Oss Collagen®, Bio-Gide®
Postoperative instructions were given, antibiotics were prescribed for 7 days (amoxicillin 500 mg t.i.d), analgesics to relieve from pain (Paracetamol 750 mg) and chlorhexidine 0.12% rinse twice a day for 15 days. Complementary, the patients were instructed to avoid chewing in the anterior region and to follow a soft diet.
Other names: Amoxicillin, Paracetamol, Chlorhexidine
Definitive implant-supported restorations were performed 6 months after dental implant placement.
Other names: Zirconia abutment and ceramic crown installation
No soft tissue graft was used
Time frame: 12 months after surgical procedure
Periimplant marginal recession in millimeters 12 months after the surgical procedure.
Time frame: 12 months
Evaluation of implant survival
Time frame: 12 months after the surgical procedure
Evaluation of mesial and distal papilla migration in millimeters 12 months after the surgical procedure
Time frame: 12 months after the surgical procedure
Evaluation of pink esthetic scores
Time frame: 12 months after the surgical procedure
Evaluation of soft tissue thickness in millimeters 12 months after the surgical procedure
Time frame: 12 months after the surgical procedure
Evaluation of bone height in millimeters in contact with the implant 12 months after the surgical procedure
Time frame: 12 months after the surgical procedure
Evaluation of gingival esthetics
Time frame: 12 months after the surgical procedure
Evaluation of bone thickness in millimeters in contact with the implant 12 months after the surgical procedure
São Paulo State University
Other
Soft and Hard Tissue Stability After Immediate Tooth Replacement With Implant in Fresh Sockets Grafted With Different Soft Tissue Grafts
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.
NCT05258019
Bone Diseases, Bone Diseases, Developmental
View Trial DetailsNCT07734935
Gingival Crevicular Fluid, Gingival Diseases
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07736833
Gingival Diseases, Gingival Recession
Tanta, Gharbia Governorate, Egypt
View Trial DetailsNCT07717398
Gingival Diseases, Gingival Recession
Tanta, Gharbia Governorate, Egypt
View Trial Details