Impact of Soft Tissue Grafts on Tissue Alterations After Immediate Tooth Replacement
September 29, 2016 updated by: São Paulo State University
Soft and Hard Tissue Stability After Immediate Tooth Replacement With Implant in Fresh Sockets Grafted With Different Soft Tissue Grafts
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).
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
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Araraquara, SP, Brazil, 14801-903
- Araraquara Dental School at the São Paulo State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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:
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:
Definitive implant-supported restorations were performed 6 months after dental implant placement.
Other Names:
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.
|
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:
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:
Definitive implant-supported restorations were performed 6 months after dental implant placement.
Other Names:
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:
|
|
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.
|
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:
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:
Definitive implant-supported restorations were performed 6 months after dental implant placement.
Other Names:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Periimplant marginal recession
Time Frame: 12 months after surgical procedure
|
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
Time Frame: 12 months
|
Evaluation of implant survival
|
12 months
|
|
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
|
12 months after the surgical procedure
|
|
Pink esthetic score
Time Frame: 12 months after the surgical procedure
|
Evaluation of pink esthetic scores
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12 months after the surgical procedure
|
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Soft tissue thickness
Time Frame: 12 months after the surgical procedure
|
Evaluation of soft tissue thickness in millimeters 12 months after the surgical procedure
|
12 months after the surgical procedure
|
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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
|
12 months after the surgical procedure
|
|
Modified pink esthetic score
Time Frame: 12 months after the surgical procedure
|
Evaluation of gingival esthetics
|
12 months after the surgical procedure
|
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Bone thickness
Time Frame: 12 months after the surgical procedure
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Evaluation of bone thickness in millimeters in contact with the implant 12 months after the surgical procedure
|
12 months after the surgical procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Elcio Marcantonio Jr, Professor, Professor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
- Belser UC, Grutter L, Vailati F, Bornstein MM, Weber HP, Buser D. Outcome evaluation of early placed maxillary anterior single-tooth implants using objective esthetic criteria: a cross-sectional, retrospective study in 45 patients with a 2- to 4-year follow-up using pink and white esthetic scores. J Periodontol. 2009 Jan;80(1):140-51. doi: 10.1902/jop.2009.080435.
- Yoshino S, Kan JY, Rungcharassaeng K, Roe P, Lozada JL. Effects of connective tissue grafting on the facial gingival level following single immediate implant placement and provisionalization in the esthetic zone: a 1-year randomized controlled prospective study. Int J Oral Maxillofac Implants. 2014 Mar-Apr;29(2):432-40. doi: 10.11607/jomi.3379.
- Roe P, Kan JY, Rungcharassaeng K, Caruso JM, Zimmerman G, Mesquida J. Horizontal and vertical dimensional changes of peri-implant facial bone following immediate placement and provisionalization of maxillary anterior single implants: a 1-year cone beam computed tomography study. Int J Oral Maxillofac Implants. 2012 Mar-Apr;27(2):393-400.
- van Steenberghe D. Outcomes and their measurement in clinical trials of endosseous oral implants. Ann Periodontol. 1997 Mar;2(1):291-8. doi: 10.1902/annals.1997.2.1.291.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
September 24, 2016
First Submitted That Met QC Criteria
September 29, 2016
First Posted (Estimate)
October 3, 2016
Study Record Updates
Last Update Posted (Estimate)
October 3, 2016
Last Update Submitted That Met QC Criteria
September 29, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- São Paulo State University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Study Data/Documents
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Individual Participant Data Set
Information comments:
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.
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Study Protocol
Information comments: 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
Information comments: 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.
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Informed Consent Form
Information comments: 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.
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Clinical Study Report
Information comments: 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.
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Analytic Code
Information comments: 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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.