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Completed

NCT Number: NCT02922075

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

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Araraquara Dental School at the São Paulo State University

Araraquara, São Paulo, 14801-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Connective tissue graft

Biological

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.

Other names: autogenous subepithelial connective tissue graft

Collagen matrix graft

Biological

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.

Other names: heterogenous graft

Immediate implant

Device

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).

Tooth extraction

Procedure

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.

Immediate restoration

Device

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.

Bone regeneration

Biological

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

Other names: Bio-Oss Collagen®, Bio-Gide®

Post operative medication

Drug

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.

Other names: Amoxicillin, Paracetamol, Chlorhexidine

Definitive prosthesis

Device

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

Other names: Zirconia abutment and ceramic crown installation

No soft tissue graft

Other

No soft tissue graft was used

Primary outcomes

  1. Periimplant marginal recession

    Time frame: 12 months after surgical procedure

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

Secondary outcomes

  1. Questionnaire of Implant survival

    Time frame: 12 months

    Evaluation of implant survival

  2. Papilla migration

    Time frame: 12 months after the surgical procedure

    Evaluation of mesial and distal papilla migration in millimeters 12 months after the surgical procedure

  3. Pink esthetic score

    Time frame: 12 months after the surgical procedure

    Evaluation of pink esthetic scores

  4. Soft tissue thickness

    Time frame: 12 months after the surgical procedure

    Evaluation of soft tissue thickness in millimeters 12 months after the surgical procedure

  5. Bone height

    Time frame: 12 months after the surgical procedure

    Evaluation of bone height in millimeters in contact with the implant 12 months after the surgical procedure

  6. Modified pink esthetic score

    Time frame: 12 months after the surgical procedure

    Evaluation of gingival esthetics

  7. Bone thickness

    Time frame: 12 months after the surgical procedure

    Evaluation of bone thickness in millimeters in contact with the implant 12 months after the surgical procedure

Sponsors and collaborators

Lead sponsor

São Paulo State University

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2015
First posted
Oct 3, 2016
Registry last updated
Oct 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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