Immediate Implants Inserted Through Open Flap, Open Flap and Bone Grafting and Flapless Techniques
Condition: Isolated Premolar Edentulous Site
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      This is a three-armed randomized controlled clinical trial aiming the estimation of
      dimensional alveolar bone changes after insertion of post-extraction implants through 3
      different surgical techniques: open flap, open flap and grafting, flapless.
    

Detailed description: 
      Background and Objectives A recent systematic review investigating dimensional alveolar bone
      changes after insertion of post-extraction implants reported that there is a lack of
      randomized controlled trials that would serve as a scientific base for building clinical
      guidelines on alveolar site treatment after insertion of post-extraction implants. Different
      studies suggest that insertion of post-extraction implants should be performed after fully
      elevating a flap and inserting bone graft in the residual space between the implant surface
      and the alveolar socket. Other investigations report insignificant differences between open
      flap and flapless approaches, whereas the insertion of bone grafts remains controversial.

      The present study is a three-armed randomized clinical controlled trial conducted with the
      following objectives:

        1. Evaluation of morphological and alveolar bone level differences (marginal bone loss) on
           post-extraction implants inserted with the following techniques: 1) open flap surgery
           alone; 2) open flap surgery and bone grafting; 3) flapless.

        2. Estimation of effectiveness of the three surgical techniques through measurement of
           secondary outcomes such as intra-operatory and post-operatory complications, pain and
           discomfort, time and costs.

      Materials and Methods

        -  This is a three-armed randomized controlled clinical trial where each arm will belong to
           one of the treatments: 1) open flap surgery alone; 2) open flap surgery and bone
           grafting; 3) flapless.

        -  The randomizing sequence will be generated from a computer program (STATA 13) by a
           statistician who will also conduct blind statistical analysis of results.

        -  All patients will be recruited prior to trial commencement. They will be extensively
           informed regarding the intervention and will sign a treatment consent.

        -  Patients will be recruited according to the following inclusion criteria: absence of any
           systemic disease that might compromise implant integration or wound healing, appropriate
           periodontal health (measured through periodontal indexes), presence of premolars with
           indications of extractions, presence of adjacent teeth, absence of fenestrations,
           presence of vestibular alveolar wall with a minimum of 0.5mm of thickness. Patients who
           have undergone CT scanning in the past 5 years and heavy smokers (more than 20
           cigarettes per day) will not be included in the study.

        -  Calculation of sample size has already been performed by an experienced statistician,
           accounting for a minimal predicted difference between groups of 1mm (SD 0.75mm) of
           marginal bone loss, alpha error of 0.05 and 90% of power. Based on these calculations, a
           total of 45 patients will be included in the study.

        -  Interventions will be performed in accordance with ethical standards as suggested by the
           Helsinki Declaration (1975). Approval of Ethical Committee of the University of Bari has
           already been obtained (reg.nr. 4987).

        -  All surgical interventions will be performed by the same experienced surgeon who will be
           informed of the type of intervention after tooth extraction (allocation concealment
           through dark sealed envelopes).

        -  The primary outcome is marginal bone loss (MBL) and alveolar bone dimensional changes
           measured through CT Cone Beam performed immediately after implant insertion and 6 months
           after. Secondary outcomes are intra-and post-operative complications, pain and
           discomfort, time and costs.

        -  Outcomes will be measured by another clinician blinded in terms of treatment allocation.

        -  Statistical analysis will be performed by an independent statistician. Statistical tests
           will include: One-way Anova, Bonferroni tests and several linear and logistic
           regressions in order to estimate potential predictive variables. Statistical
           significance will be set at .05.

        -  Interruption of study will be considered in the following situations: 1.preliminary
           observation of highly significant difference between techniques indicating one technique
           highly superior; 2. big number of lost to follow-up (bigger than that considered during
           sample size calculation)

        -  Patients will be excluded from the study in the following cases: missing follow-up
           hygiene controls at 1 and 3 months post-intervention, missing 6 months follow-up
           control, poor cooperation in terms of domestic oral hygiene (periodontal indexes
           measured), income of systemic or local diseases that might compromise outcomes.
    

Intervention name(s): Open flap immediate implant; Open flap immediate implant and bone grafting; Flapless immediate implant
Intervention type(s): Device; Device; Device
Intervention description(s): Post-extraction implants will be inserted through open flap, without bone grafting; Post-extraction implants will be inserted through open flap, adding bone grafting; Post-extraction implants will be inserted without elevating flap or inserting bone grafting
Other intervention name(s): Dental implant; Dental implant, bone grafting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: post-extraction dental implant; immediate dental implant; open flap; flapless; bone grafting; CT Cone Beam