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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02922075
Enrollment
24
Registered
2016-10-03
Start date
2013-02-28
Completion date
2015-06-30
Last updated
2016-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implants, Tooth Socket

Keywords

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

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.

Interventions

BIOLOGICALConnective tissue graft

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.

BIOLOGICALCollagen matrix graft

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.

DEVICEImmediate implant

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).

PROCEDURETooth extraction

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.

DEVICEImmediate restoration

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.

BIOLOGICALBone regeneration

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

DRUGPost operative medication

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.

DEVICEDefinitive prosthesis

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

OTHERNo soft tissue graft

No soft tissue graft was used

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
São Paulo State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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;

Design outcomes

Primary

MeasureTime frameDescription
Periimplant marginal recession12 months after surgical procedurePeriimplant marginal recession in millimeters 12 months after the surgical procedure.

Secondary

MeasureTime frameDescription
Modified pink esthetic score12 months after the surgical procedureEvaluation of gingival esthetics
Questionnaire of Implant survival12 monthsEvaluation of implant survival
Papilla migration12 months after the surgical procedureEvaluation of mesial and distal papilla migration in millimeters 12 months after the surgical procedure
Bone height12 months after the surgical procedureEvaluation of bone height in millimeters in contact with the implant 12 months after the surgical procedure
Soft tissue thickness12 months after the surgical procedureEvaluation of soft tissue thickness in millimeters 12 months after the surgical procedure
Bone thickness12 months after the surgical procedureEvaluation of bone thickness in millimeters in contact with the implant 12 months after the surgical procedure
Pink esthetic score12 months after the surgical procedureEvaluation of pink esthetic scores

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026