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Clinical Trials/NCT02922075
NCT02922075
Completed
Phase 4

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

São Paulo State University1 site in 1 country24 target enrollmentFebruary 2013

Overview

Phase
Phase 4
Intervention
Bone regeneration
Conditions
Tooth Socket
Sponsor
São Paulo State University
Enrollment
24
Locations
1
Primary Endpoint
Periimplant marginal recession
Status
Completed
Last Updated
9 years ago

Overview

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).

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.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
June 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
São Paulo State University
Responsible Party
Sponsor

Eligibility 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;

Arms & Interventions

CTL

No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Bone regeneration

CTL

No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Immediate implant

CTL

No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Tooth extraction

CTL

No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Immediate restoration

CTL

No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Post operative medication

CTL

No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Definitive prosthesis

CTL

No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: No soft tissue graft

CM

Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Collagen matrix graft

CM

Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Immediate implant

CM

Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Tooth extraction

CM

Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Immediate restoration

CM

Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Bone regeneration

CM

Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Post operative medication

CM

Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Definitive prosthesis

CTG

Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Connective tissue graft

CTG

Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Immediate implant

CTG

Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Tooth extraction

CTG

Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Immediate restoration

CTG

Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Bone regeneration

CTG

Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Post operative medication

CTG

Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Intervention: Definitive prosthesis

Outcomes

Primary Outcomes

Periimplant marginal recession

Time Frame: 12 months after surgical procedure

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

Secondary Outcomes

  • 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)
  • Modified pink esthetic score(12 months after the surgical procedure)
  • Bone thickness(12 months after the surgical procedure)

Study Sites (1)

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