Soft and Hard Tissue Stability After Immediate Tooth Replacement With Implant in Fresh Sockets Grafted With Different Soft Tissue Grafts
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Periimplant marginal recession
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Biological)
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 (Device)
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 (Procedure)
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 (Device)
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 (Drug)
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 (Device)
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 (Other)
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 (Biological)
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 (Device)
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 (Procedure)
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 (Device)
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 (Biological)
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 (Drug)
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 (Device)
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 (Biological)
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 (Device)
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 (Procedure)
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 (Device)
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 (Biological)
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 (Drug)
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 (Device)
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)