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

São Paulo State University

Status and phase: Completed; Phase 4

Conditions: Dental Implants; Tooth Socket

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02922075

São Paulo State University

Details and patient eligibility

About

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).

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups, including a placebo group

CTL

Placebo Comparator group

Description:

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

Treatment:

Device: Definitive prosthesis

Biological: Bone regeneration

Device: Immediate implant

Procedure: Tooth extraction

Other: No soft tissue graft

Device: Immediate restoration

Drug: Post operative medication

CM

Experimental group

Description:

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

Treatment:

Device: Definitive prosthesis

Biological: Bone regeneration

Device: Immediate implant

Procedure: Tooth extraction

Device: Immediate restoration

Biological: Collagen matrix graft

Drug: Post operative medication

CTG

Experimental group

Description:

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

Treatment:

Device: Definitive prosthesis

Biological: Bone regeneration

Device: Immediate implant

Biological: Connective tissue graft

Procedure: Tooth extraction

Device: Immediate restoration

Drug: Post operative medication