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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTL | Placebo Comparator | No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis. |
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| CM | Experimental | Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis. |
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| CTG | Experimental | Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connective tissue graft | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Periimplant marginal recession | Periimplant marginal recession in millimeters 12 months after the surgical procedure. | 12 months after surgical procedure |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elcio Marcantonio Jr, Professor | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Araraquara Dental School at the São Paulo State University | Araraquara | São Paulo | 14801-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24683571 | Background | 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. | |
| 22442780 |
| Label | URL |
|---|---|
| All data can be downloaded from the website, if there are any questions please feel free to contact us. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
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| Collagen matrix graft | Biological | 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. |
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| Immediate implant | Device | 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). |
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| Tooth extraction | Procedure | 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. |
|
| Immediate restoration | Device | 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. |
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| Bone regeneration | Biological | All sites received a non-cross linked collagen membrane and deproteinized bovine bone mineral containing 10% of porcine collagen. |
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| Post operative medication | Drug | 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. |
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| Definitive prosthesis | Device | Definitive implant-supported restorations were performed 6 months after dental implant placement. |
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| No soft tissue graft | Other | No soft tissue graft was used |
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| 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 |
| 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. |
| 9151562 | Background | 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. |
| 16307569 | Background | 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. |
| 19228100 | Background | 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. |
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 | View IPD | 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 | View IPD | 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 | View IPD | 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 | View IPD | 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 | View IPD | 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. |
| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
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| ID | Term |
|---|---|
| D057893 | Immediate Dental Implant Loading |
| D014081 | Tooth Extraction |
| D001861 | Bone Regeneration |
| C106416 | Bio-Gide |
| D000658 | Amoxicillin |
| D000082 | Acetaminophen |
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D003758 | Dental Implantation, Endosseous |
| D003757 | Dental Implantation |
| D013516 | Oral Surgical Procedures, Preprosthetic |
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D003813 | Dentistry |
| D011476 | Prosthodontics |
| D016723 | Bone Remodeling |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D012038 | Regeneration |
| D001686 | Biological Phenomena |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
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