In the Treatment of Implants With Different Methods; Early Bone Loss and Patient Satisfaction
Condition: Dental Implants
Study type: Interventional

Summary: 
      The aim of this clinical study is to compare two different approaches during dental implant
      applications. One group of patients in the study received flapless approach which is
      performed without surgical reflection of soft tissues (gums) during implant surgery. In the
      control group of the study, patients received conventional flap approach in which flap
      reflections performed on soft tissues (gums) of the patients.

      After the surgery patients were monitored for marginal bone loss around implants and
      discomfort after the surgery for 3 months. And received data statistically analyzed to
      compare the different surgical procedures.
    

Detailed description: 
      Filling the Case Report Form for each registered patient and signed by the responsible
      investigator or an authorized representative of the study staff. This also applies to records
      for patients who could not complete the study (even if a case report form was prepared, even
      during screening prior to randomization). If a patient withdraws from the study, the reason
      for this is recorded in the Case report form. If a patient withdraws from the study because
      of a limiting adverse event, all necessary efforts will be made to clearly document the
      result.

      All forms must be filled with a typewriter or an indelible ink pen and must be readable.
      Errors can be crossed out, but errors cannot be deleted; the correction is entered and the
      change is initialed and dated by the investigator or his authorized representative. The
      researcher should ensure the accuracy, completeness and legibility of the data reported to
      the sponsor in the case report forms and all required reports and that it was processed on
      time.

      The researcher is responsible for the accuracy of the data transferred on the forms and will
      sign these forms in the sense of showing their compatibility with the recorded data.

      As a result of the power analysis made with G * Power3.1 (Franz Faul, UniversitätKiel,
      Germany) software program, it has been determined that the sampling number consisting of 20
      people with 0.8 effect size and α = 0.05 significance level generates more than 80% power. it
      was deemed appropriate to include a total of 24 people in the study. Karim M. Ahmed A, Salah
      Abd Elfatah B, Mohamed Abd El-Mageed Katamish's ''Crestal bone loss of standard implant
      versus platform switch implant design using minimal invasive technique'' article is used as a
      reference for marginal bone loss data calculation.

      Patients with sufficient amount of bone were included in the study after bone sounding and x
      rays were evaluated after local anesthesia before surgery. By an unbiased researcher, the
      patients were recruited to the groups using the envelope method; control group (with flap
      raised) or test group (without flap raised) were assigned.

      A total of 24 patients complying with these criteria were included in the study and a total
      of 37 implants were applied to the patients.

      Implant applications of the patients in the control group were performed by lifting the flap.
      The implants of the patients included in the test group were applied without lifting the
      flap.

      For each implant in the study marginal bone loss were evaluated; Digital bite-wing x-rays
      taken with a standard technique were used.Bite-wing x-rays taken were standardized with bite
      blocks on the film holder prepared individually for each patient. From each implant site; two
      x-rays were taken first immediately after implant surgery and the second three months later,
      just before the uncovering session of the implants. Digital bite-wing x-rays were transferred
      to RadiAnt Dicom Viewer program and measurements were made on them. Implant diameter values
      which is known in the images are accepted as reference.The diameter in the image was measured
      and a coefficient was obtained by dividing the real diameter to measurement on image. In the
      images, the distance between the most coronal point of the implant neck and the point where
      the implant bone contact first occurred was measured. This distance was divided by the
      coefficient obtained and its actual values are obtained in mm.The difference between these
      distances at two time points were recorded in patient forms as marginal bone loss. In
      statistical analysis, comparisons between groups were made.

      All the individuals included in the study came to the control appointments on the 3rd and 7th
      days after implant surgery, and the sutures were also taken on the 7th day. All patients were
      asked to fill the Turkish translation of Oral Health Impact Profile (OHIP-14) forms three
      times: preoperatively, postoperative day 3, and postoperative day 7. Visual Analog Scale
      (VAS) forms were asked to be marked by the patients on the 3rd and 7th days after the
      operation. VAS forms were prepared as a horizontal line with one side being the lowest score
      and the other side with highest score. VAS forms were prepared to be in 0-100 mm and the
      point marked by the patient was measured in cm. In VAS forms, patients were asked to mark
      according to their post-operative pain status.

      Statistical analysis of the data in this study was done with Statistical Package for the
      Social Sciences (SPSS) 20 (International Business Machines Corporation Somers, New York, USA)
      package program.In the evaluation of the data, besides descriptive statistical methods (mean,
      standard deviation), T test was used for comparisons between groups. ANOVA test was used for
      multiple group comparisons. Statistical significance level was determined as p <0.05 .
    

Intervention name(s): Flapless implant surgery.; Conventional implant surgery.
Intervention type(s): Procedure; Procedure
Intervention description(s): Local anesthesia will be applied to the patients in the test group, and then the implant socket will be prepared without removing the flap and a dental implant will be placed.
Bite-wing film will be taken to control the implants in the same session after surgery, and patients will be given VAS (visual analog scale) to perform their assessment of pain on the 3rd day and 7th day. Patients will be given an appointment again after 3 months of treatment. In this session, implants will be evaluated with bite-wing film.; Local anesthesia will be applied to the patients in the control group, and then the implant socket will be prepared after reflecting the flap and a dental implant will be placed.
Patients in the control group will receive a full thickness flap elevation and an implant socket will be prepared afterwards the implant will be placed and then the flap will be closed with 4-0 silk suture.
Bite-wing film will be taken from both groups to control the implants in the same session after surgery, and patients will be given VAS (visual analog scale) to perform their assessment of pain on the 3rd day and 7th day. Patients will be given an appointment again after 3 months of treatment. In this session, implants will be evaluated with bite-wing film.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental Implants; marginal bone loss; flapless implant surgery