رادار التجارب السريرية

bucco-palatal dimensional ridge changes

The Bucco-palatal dimensional ridge alterations were assessed via digital scans to assess the difference and changes in the overall ridge dimensions (mm). Reference points were assigned in the baseline measurements of the scans using the Standard Triangle Language (STL) files of the models obtained via digital scanning to allow standardized comparisons after 3,6, and 9 months. The 3D software allowed the alignment of the reference points identified on the models.

Pre-operative , day 1 , then 3,6 , 9 months later

Pink esthetic score (PES)

Pink esthetic score will be recorded for five variables: "mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, and root convexity/soft tissue color and texture at the facial aspect of the implant site". A score of 2, 1, or 0 will be assigned to all five PES parameters. The two papillary scores (mesial and distal) will be assessed for the complete presence (score 2), incomplete presence (score 1) or absence (score0) of papillary tissue. The curvature of the facial soft tissue line, also defined as the line of emergence of the implant restoration from the soft tissues, will be evaluated as being identical (score 2 ), slightly different (score 1), or markedly different (score 0) compared to the natural control tooth and thus, provided a natural symmetrical or disharmonious appearance and in comparison to the contralateral tooth in terms of an identical vertical level (score 2), a slight (\<1 mm) discrepancy (score 1), or a major (\>1 mm) discrepancy

Baseline, 3 , 6,and 9 months

• Volumetric changes ( digital scanner )

To assess the volumetric differences between the baseline, 3, 6 and 9 months postoperatively, digital replica using scanner. Digital replicas were produced resembling various time intervals during treatment. Superimposing the different replicas of each case utilizing the best fit algorithm by using reference points from the tooth surfaces. The implant site region was delineated by the mucogingival line, the mesial and distal papillary midline, and the alveolar crest. Thus, alterations in volume between the digitized superimposed replicas could be recorded. (Akcali et al., 2015).

Pre-operative ,day 1 , 3,6 ,and 9 months

• Mid facial mucosal recession (MFR)

changes were assessed by three measurements, taken at the tip of the mesial papillae, tip of the distal papillae, and mid-facial gingival margin, preoperative, once at baseline and were compared to measurements after ,3, 6, and 9 months.

Pre-operative baseline and 3,6,9 months

• Labial bone thickness

Assessed on the sagittal section of the CBCT at three points: the implant platform (crestal thickness), half of the implant length (middle thickness) and implant apex (apical thickness).

The labial bone thickness will be measured at day 1and 9 months later

• Soft tissue thickness (STT)

using an anesthetic needle with rubber stopper to pierce the gingiva horizontally and perpendicular to the long axis of the tooth till bone contact 2mm coronal to the MGJ and in the mid distance mesiodistally. The part of the instrument penetrating into soft tissue will be measured in mm. (Cairo et al 2017)

measured at baseline and 9 months

Visual analogue scale measures postoperative pain (VAS)

Pain score is reported by the patient directly through The Visual Analogue Scale score (from 0 to 10. 0: no pain, 1: minimal pain, 5: moderate pain, 10: severe pain)

3 days , 7 days ,and 14 days

• Probing depth

Probing depth is the distance from the gingival margin to the base of the sulcus or periodontal pocket, measured using a periodontal probe.

Baseline and 9 months

• Plaque index

simple method used to record the presence of dental plaque on tooth surfaces. It is commonly called the O'Leary Plaque Control Record (PCR).

Baseline and 9 months

• Bleeding index

clinical index used to evaluate gingival inflammation by measuring bleeding after gentle probing. 1. A periodontal probe is gently inserted into the gingival sulcus. 2. The probe is moved along the gingival margin with light pressure. 3. The site is observed for bleeding within about 10-30 second

Baseline and 9 months