PES After Soft Tissue Augmentation Using CTG Around Immediate Dental Implants Versus Immediate Dental Implants Alone in Esthetic Zone
Condition: Soft Tissue Augmentation
Study type: Interventional

Summary: 
      The goal of the present study is to compare the esthetic result and stability of gingival
      tissue over the immediate implant only and immediate implant with connective tissue in
      patients with single non-restorable tooth in the esthetic zone. The main null hypothesis to
      be tested is that the addition of SCTG to immediately placed implants will not significantly
      differ from immediately placed implant alone as regard gingival tissue stability.
    

Detailed description: 
      Implant became a treatment modality for replacing missing or non-restorable teeth, providing
      clinical success rate and esthetic outcome. (1) In esthetic zone the main goal is not only
      the preservation of function but also the preservation of the esthetics. The esthetic outcome
      of implant supported restoration depend on the soft tissue volume and the soft tissue
      contour. (2) The placement of immediate implant after tooth extraction was proved as a very
      high success rate treatment modality. It provided several advantages such as reduction of the
      time between tooth extraction and the placement of prosthesis, reduction of the number of
      surgical treatments (3) and increase osteointegration between bone and implant surface (4).

      Considering the survival rate of immediate implantation versus delayed implantation there is
      no significant difference with an overall success rate of 99.6%, it is just considered as a
      successful treatment modality, based on 802 implants (5).

      On the other hand disadvantage related to esthetic outcome has been reported, showing facial
      gingival recession following the first year of function due to labial bone plate resorption.
      (6, 2).

      A systematic review by Sanz et al.,(2012) compared the reduction of bone height and bone
      width between two groups the control group was delayed implant placement and the studied
      group was immediate implant placement and the mean difference between groups was of 13.11%
      (95% CI: from 3.83 to 22.4; P = 0.057) and 19.85% (95% CI: from 13.85 to 25.81)respectively,
      concluding that the early placement of dental implants after tooth extraction offers
      advantages in terms of soft and hard tissue preservation, compared with delayed implant
      placement , which affect the aesthetic (7 ) As a sequence of dimensional ridge alterations
      that occur following tooth extraction many studies reported a recession of marginal
      peri-implant mucosa, which affect the aesthetic outcome (8, 9, and 10).

      A study made by Migliorati et al., (2015) between two groups, the control group (immediate
      loading implant treated without raising a flap) and the test group (immediate loaded implant
      treated with sub-epithelial connective tissue graft (SCTG) using the tunnel technique in the
      labial area) Both groups (47 implants) received deproteinized bovine bone minerals and
      implants were successfully integrated with a follow up period 2-year examination . Moreover
      the mean recession in the control group was 0.71mm (17.58%), one third of the control group
      reported recession >1mm, and mean pink aesthetic score (PES) was 6.65, resulting in bad
      aesthetic. The test group showed an increase of the keratinized mucosa (KM) with a mean of
      34.29% (0.5mm) and a mean recession of 0.2mm (10.01%), only one case (4%) showed recession
      >1mm and the mean PES was 8. The thickening of soft tissue by the addition of SCTG, lead to
      compensation and maintenance of the loss of bone volume in the labial area (11).

      The addition of sub epithelial connective tissue graft (SCTG) to the immediate implant was
      suggested for facial gingival biotype conversation. It was proved to be successful in
      preserving soft tissue levels. (12)

      A systematic review was made to investigate if the addition of SCTG overcome the disadvantage
      of placement of immediate implant only or not, but unfortunately the included studies had
      different techniques and the number of the patients in those studies was few thus further RCT
      was necessary (13).
    

Intervention name(s): connective tissue graft; immediate implant
Intervention type(s): Procedure; Device
Intervention description(s): patient will receive immediate implant and connective tissue graft; patient will receive immediate implant with connective tissue graft.
Other intervention name(s): subepithelial connective tissue graft; post extraction dental implant
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible patients will be randomized using sequence generation program (Random.org in equal proportions between control group (immediate implant alone) and study group (immediate implant covered with sub-epithelial connective tissue graft with full coverage technique).
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: immediate implant; connective tissue graft