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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Tooth Socket, Dental Implants

Intervention / Treatment
-----------------
* Biological: Connective tissue graft
* Biological: Collagen matrix graft
* Device: Immediate implant
* Procedure: Tooth extraction
* Device: Immediate restoration
* Biological: Bone regeneration
* Drug: Post operative medication
* Device: Definitive prosthesis
* Other: No soft tissue graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of a failing maxillary incisor with neighbouring teeth and harmonic gingival contour; Operated area with appropriate palatal/apical bone to install the implant; A buccal wall defect confirmed by cone beam computed tomography; Clinical attachment level > 3 mm; Good oral hygiene with visible plaque index < 20%; No bone loss in the neighbouring teeth; Implant primary stability > 32N Exclusion Criteria: History of periodontal surgeries in the failing tooth; Occlusal instability; Systemic alterations that could compromise the surgical procedure, such ass smokers, bruxists; drug users; patients with diabetes or pregnants. Active infection involving the gingival margin Patients undergoing radiotherapy in the head and neck area. Patients presented history of bone associated diseases or medication affecting bone metabolism;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: CTL<br>No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis. | Device: Immediate implant<br>* 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).<br>Procedure: Tooth extraction<br>* 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.<br>Device: Immediate restoration<br>* 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.<br>Biological: Bone regeneration<br>* All sites received a non-cross linked collagen membrane and deproteinized bovine bone mineral containing 10% of porcine collagen.<br>* Other names: Bio-Gide®;Drug: Post operative medication<br>* 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.<br>* Other names: Chlorhexidine;Device: Definitive prosthesis<br>* Definitive implant-supported restorations were performed 6 months after dental implant placement.<br>* Other names: Zirconia abutment and ceramic crown installation;Other: No soft tissue graft<br>* No soft tissue graft was used<br>|
| Experimental: CM<br>Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis. | Biological: Collagen matrix graft<br>* 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.<br>* Other names: heterogenous graft;Device: Immediate implant<br>* 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).<br>Procedure: Tooth extraction<br>* 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.<br>Device: Immediate restoration<br>* 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.<br>Biological: Bone regeneration<br>* All sites received a non-cross linked collagen membrane and deproteinized bovine bone mineral containing 10% of porcine collagen.<br>* Other names: Bio-Gide®;Drug: Post operative medication<br>* 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.<br>* Other names: Chlorhexidine;Device: Definitive prosthesis<br>* Definitive implant-supported restorations were performed 6 months after dental implant placement.<br>* Other names: Zirconia abutment and ceramic crown installation;|
| Experimental: CTG<br>Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis. | Biological: Connective tissue graft<br>* 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.<br>* Other names: autogenous subepithelial connective tissue graft;Device: Immediate implant<br>* 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).<br>Procedure: Tooth extraction<br>* 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.<br>Device: Immediate restoration<br>* 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.<br>Biological: Bone regeneration<br>* All sites received a non-cross linked collagen membrane and deproteinized bovine bone mineral containing 10% of porcine collagen.<br>* Other names: Bio-Gide®;Drug: Post operative medication<br>* 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.<br>* Other names: Chlorhexidine;Device: Definitive prosthesis<br>* Definitive implant-supported restorations were performed 6 months after dental implant placement.<br>* Other names: Zirconia abutment and ceramic crown installation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periimplant marginal recession | Periimplant marginal recession in millimeters 12 months after the surgical procedure. | 12 months after surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire of Implant survival | Evaluation of implant survival | 12 months | 
| Papilla migration | Evaluation of mesial and distal papilla migration in millimeters 12 months after the surgical procedure | 12 months after the surgical procedure | 
| Pink esthetic score | Evaluation of pink esthetic scores | 12 months after the surgical procedure | 
| Soft tissue thickness | Evaluation of soft tissue thickness in millimeters 12 months after the surgical procedure | 12 months after the surgical procedure | 
| Bone height | Evaluation of bone height in millimeters in contact with the implant 12 months after the surgical procedure | 12 months after the surgical procedure | 
| Modified pink esthetic score | Evaluation of gingival esthetics | 12 months after the surgical procedure | 
| Bone thickness | Evaluation of bone thickness in millimeters in contact with the implant 12 months after the surgical procedure | 12 months after the surgical procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gingival recession, immediate implant and provisional placement, bone graft, connective tissue graft, collagen matrix