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

NCT02922075 | Completed Phase 4

• 1 other identifier: São Paulo State University
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Tooth Socket; Dental Implants

Keywords

gingival recession; immediate implant and provisional placement; bone graft; connective tissue graft; collagen matrix

Outcome Measures

Primary Outcomes (1)

• Periimplant marginal recession

  Periimplant marginal recession in millimeters 12 months after the surgical procedure.

  12 months after surgical procedure

Secondary Outcomes (7)

• Questionnaire of Implant survival

  12 months

• Papilla migration

  12 months after the surgical procedure

• Pink esthetic score

  12 months after the surgical procedure

• Soft tissue thickness

  12 months after the surgical procedure

• Bone height

  12 months after the surgical procedure

Study Arms (3)

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.

Device: Immediate implant; Procedure: Tooth extraction; Device: Immediate restoration; Biological: Bone regeneration; Drug: Post operative medication; Device: Definitive prosthesis; Other: No soft tissue graft

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.

Biological: Collagen matrix graft; Device: Immediate implant; Procedure: Tooth extraction; Device: Immediate restoration; Biological: Bone regeneration; Drug: Post operative medication; Device: Definitive prosthesis

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.

Biological: Connective tissue graft; Device: Immediate implant; Procedure: Tooth extraction; Device: Immediate restoration; Biological: Bone regeneration; Drug: Post operative medication; Device: Definitive prosthesis

Interventions

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.

Also known as: autogenous subepithelial connective tissue graft

CTG

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.

Also known as: heterogenous graft

CM

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).

CM; CTG; CTL

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.

CM; CTG; CTL

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.

CM; CTG; CTL

Bone regeneration BIOLOGICAL

All sites received a non-cross linked collagen membrane and deproteinized bovine bone mineral containing 10% of porcine collagen.

Also known as: Bio-Oss Collagen®, Bio-Gide®

CM; CTG; CTL

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.

Also known as: Amoxicillin, Paracetamol, Chlorhexidine

CM; CTG; CTL

Definitive prosthesis DEVICE

Definitive implant-supported restorations were performed 6 months after dental implant placement.

Also known as: Zirconia abutment and ceramic crown installation

CM; CTG; CTL

No soft tissue graft OTHER

No soft tissue graft was used

CTL

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• São Paulo State University: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Araraquara Dental School at the São Paulo State University

Araraquara, São Paulo, 14801-903, Brazil

Location

Related Publications (5)

• 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.

  PMID: 24683571 BACKGROUND

• 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.

  PMID: 22442780 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.

  PMID: 9151562 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.

  PMID: 16307569 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.

  PMID: 19228100 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Gingival Recession

Interventions

Immediate Dental Implant Loading; Tooth Extraction; Bone Regeneration; Bio-Gide; Amoxicillin; Acetaminophen; Chlorhexidine

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics; Bone Remodeling; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Regeneration; Biological Phenomena; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Aniline Compounds; Amines; Biguanides; Guanidines; Amidines

Study Officials

• Elcio Marcantonio Jr, Professor

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2016
• First Posted: October 3, 2016
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2015
• Last Updated: October 3, 2016

Record last verified: 2016-09

Locations

BR (1)