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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922075
Recruitment Status : Completed
First Posted : October 3, 2016
Last Update Posted : October 3, 2016
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
São Paulo State University

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).

Condition or disease Intervention/treatment Phase
Tooth Socket Dental Implants 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 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Soft and Hard Tissue Stability After Immediate Tooth Replacement With Implant in Fresh Sockets Grafted With Different Soft Tissue Grafts
Study Start Date : February 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Placebo Comparator: CTL
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
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.
Other Names:
  • Bio-Oss Collagen®
  • Bio-Gide®

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.
Other Names:
  • Amoxicillin
  • Paracetamol
  • Chlorhexidine

Device: Definitive prosthesis
Definitive implant-supported restorations were performed 6 months after dental implant placement.
Other Name: Zirconia abutment and ceramic crown installation

Other: No soft tissue graft
No soft tissue graft was used

Experimental: CM
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
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 Name: heterogenous graft

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.
Other Names:
  • Bio-Oss Collagen®
  • Bio-Gide®

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.
Other Names:
  • Amoxicillin
  • Paracetamol
  • Chlorhexidine

Device: Definitive prosthesis
Definitive implant-supported restorations were performed 6 months after dental implant placement.
Other Name: Zirconia abutment and ceramic crown installation

Experimental: CTG
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
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 Name: autogenous subepithelial connective tissue graft

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.
Other Names:
  • Bio-Oss Collagen®
  • Bio-Gide®

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.
Other Names:
  • Amoxicillin
  • Paracetamol
  • Chlorhexidine

Device: Definitive prosthesis
Definitive implant-supported restorations were performed 6 months after dental implant placement.
Other Name: Zirconia abutment and ceramic crown installation




Primary Outcome Measures :
  1. Periimplant marginal recession [ Time Frame: 12 months after surgical procedure ]
    Periimplant marginal recession in millimeters 12 months after the surgical procedure.


Secondary Outcome Measures :
  1. Questionnaire of Implant survival [ Time Frame: 12 months ]
    Evaluation of implant survival

  2. Papilla migration [ Time Frame: 12 months after the surgical procedure ]
    Evaluation of mesial and distal papilla migration in millimeters 12 months after the surgical procedure

  3. Pink esthetic score [ Time Frame: 12 months after the surgical procedure ]
    Evaluation of pink esthetic scores

  4. Soft tissue thickness [ Time Frame: 12 months after the surgical procedure ]
    Evaluation of soft tissue thickness in millimeters 12 months after the surgical procedure

  5. Bone height [ 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

  6. Modified pink esthetic score [ Time Frame: 12 months after the surgical procedure ]
    Evaluation of gingival esthetics

  7. Bone thickness [ 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



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Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922075


Locations
Layout table for location information
Brazil
Araraquara Dental School at the São Paulo State University
Araraquara, SP, Brazil, 14801-903
Sponsors and Collaborators
São Paulo State University
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Layout table for investigator information
Principal Investigator: Elcio Marcantonio Jr, Professor Professor

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

Public title: Stability of the architecture of the hard and soft tissue after immediate tooth replacement with implants in fresh grafted sockets.

All data can be downloaded from the website, if there are any questions please feel free to contact us.


Study Protocol  This link exits the ClinicalTrials.gov site
Public title: Stability of the architecture of the hard and soft tissue after immediate tooth replacement with implants in fresh grafted sockets. All data can be downloaded from the website, if there are any questions please feel free to contact us.
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Public title: Stability of the architecture of the hard and soft tissue after immediate tooth replacement with implants in fresh grafted sockets. All data can be downloaded from the website, if there are any questions please feel free to contact us.
Informed Consent Form  This link exits the ClinicalTrials.gov site
Public title: Stability of the architecture of the hard and soft tissue after immediate tooth replacement with implants in fresh grafted sockets. All data can be downloaded from the website, if there are any questions please feel free to contact us.
Clinical Study Report  This link exits the ClinicalTrials.gov site
Public title: Stability of the architecture of the hard and soft tissue after immediate tooth replacement with implants in fresh grafted sockets. All data can be downloaded from the website, if there are any questions please feel free to contact us.
Analytic Code  This link exits the ClinicalTrials.gov site
Public title: Stability of the architecture of the hard and soft tissue after immediate tooth replacement with implants in fresh grafted sockets. All data can be downloaded from the website, if there are any questions please feel free to contact us.

Publications:
Layout table for additonal information
Responsible Party: São Paulo State University
ClinicalTrials.gov Identifier: NCT02922075    
Other Study ID Numbers: São Paulo State University
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by São Paulo State University:
gingival recession
immediate implant and provisional placement
bone graft
connective tissue graft
collagen matrix
Additional relevant MeSH terms:
Layout table for MeSH terms
Acetaminophen
Amoxicillin
Chlorhexidine
Chlorhexidine gluconate
Anti-Bacterial Agents
Anti-Infective Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Infective Agents, Local
Disinfectants
Dermatologic Agents