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

Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922075
• Other study ID #: São Paulo State University
• Status: Completed
• Phase: Phase 4
• First received: September 24, 2016
• Last updated: September 29, 2016
• Start date: February 2013
• Est. completion date: June 2015

Study information

• Verified date: September 2016
• Source: São Paulo State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Implants
• Tooth Socket

Intervention

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.
• 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

Locations

Country	Name	City	State
Brazil	Araraquara Dental School at the São Paulo State University	Araraquara	SP

Sponsors (3)

Lead Sponsor	Collaborator
São Paulo State University	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Belser UC, Grütter 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 . — View Citation

Fürhauser 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. — View Citation

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. — View Citation

van Steenberghe D. Outcomes and their measurement in clinical trials of endosseous oral implants. Ann Periodontol. 1997 Mar;2(1):291-8. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periimplant marginal recession	Periimplant marginal recession in millimeters 12 months after the surgical procedure.	12 months after surgical procedure	No
Secondary	Questionnaire of Implant survival	Evaluation of implant survival	12 months	No
Secondary	Papilla migration	Evaluation of mesial and distal papilla migration in millimeters 12 months after the surgical procedure	12 months after the surgical procedure	No
Secondary	Pink esthetic score	Evaluation of pink esthetic scores	12 months after the surgical procedure	No
Secondary	Soft tissue thickness	Evaluation of soft tissue thickness in millimeters 12 months after the surgical procedure	12 months after the surgical procedure	No
Secondary	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	No
Secondary	Modified pink esthetic score	Evaluation of gingival esthetics	12 months after the surgical procedure	No
Secondary	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	No

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