NCT02922075

Impact of Soft Tissue Grafts on Tissue Alterations After Immediate Tooth Replacement

Soft and Hard Tissue Stability After Immediate Tooth Replacement With Implant in Fresh Sockets Grafted With Different Soft Tissue Grafts

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: São Paulo State University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Tooth Socket
• Dental Implants

Interventions

Type	Name	Description
BIOLOGICAL	Connective tissue graft	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.
BIOLOGICAL	Collagen matrix 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.
DEVICE	Immediate implant	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).
PROCEDURE	Tooth extraction	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.
DEVICE	Immediate restoration	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.
BIOLOGICAL	Bone regeneration	All sites received a non-cross linked collagen membrane and deproteinized bovine bone mineral containing 10% of porcine collagen.
DRUG	Post operative medication	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.
DEVICE	Definitive prosthesis	Definitive implant-supported restorations were performed 6 months after dental implant placement.
OTHER	No soft tissue graft	No soft tissue graft was used

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-12-01
• Completion: 2015-06-01
• First posted: 2016-10-03
• Last updated: 2016-10-03

Locations

1 site across 1 country: Brazil