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

Phase 4

Completed

• Conditions: Tooth Socket; Dental Implants
• Interventions: Device: Immediate implant; Biological: Collagen matrix graft; Biological: Connective tissue graft; Procedure: Tooth extraction; Device: Immediate restoration; Biological: Bone regeneration; Drug: Post operative medication; Device: Definitive prosthesis; Other: No soft tissue graft

• Registration Number: NCT02922075
• Lead Sponsor: São Paulo State University

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.

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2013-12
• Study Completion: 2015-06
• Status Verified: 2016-09
• Study First Submitted: 2016-09-24
• Study First Submitted QC: 2016-09-29
• Last Update Submitted: 2016-09-29
• Study First Posted: 2016-10-03
• Last Update Posted: 2016-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTL	Tooth extraction	No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CTL	Immediate restoration	No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CTL	Bone regeneration	No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CTL	Post operative medication	No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CTL	Immediate implant	No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CTL	Definitive prosthesis	No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CTL	No soft tissue graft	No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CM	Collagen matrix graft	Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CM	Immediate implant	Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CM	Tooth extraction	Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CM	Immediate restoration	Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CM	Bone regeneration	Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CM	Post operative medication	Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CM	Definitive prosthesis	Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CTG	Immediate implant	Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CTG	Connective tissue graft	Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CTG	Tooth extraction	Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CTG	Immediate restoration	Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CTG	Bone regeneration	Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CTG	Post operative medication	Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
CTG	Definitive prosthesis	Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Questionnaire of Implant survival	12 months	Evaluation of implant survival
Papilla migration	12 months after the surgical procedure	Evaluation of mesial and distal papilla migration in millimeters 12 months after the surgical procedure
Pink esthetic score	12 months after the surgical procedure	Evaluation of pink esthetic scores
Soft tissue thickness	12 months after the surgical procedure	Evaluation of soft tissue thickness in millimeters 12 months after the surgical procedure
Bone height	12 months after the surgical procedure	Evaluation of bone height in millimeters in contact with the implant 12 months after the surgical procedure
Modified pink esthetic score	12 months after the surgical procedure	Evaluation of gingival esthetics
Bone thickness	12 months after the surgical procedure	Evaluation of bone thickness in millimeters in contact with the implant 12 months after the surgical procedure

Trial Locations

Locations (1)

Araraquara Dental School at the São Paulo State University; 🇧🇷 Araraquara, SP, Brazil