Abstract Statement of the problem: Peri-implant soft-tissue augmentation procedures can be broadly divided into two groups, depending on their primary therapeutic objective: (1) Peri-implant soft-tissue phenotype modification and (2) Treatment of peri-implant marginal mucosa defects (PMMDs), also known as peri-implant soft-tissue dehiscences. Aim of the study: The aim of this study will be to evaluate the efficacy of the Omega roll envelope flap (OREF) technique compared to the conventional envelope split-thickness flap technique combined with an autogenous connective tissue graft, in enhancing Peri-implant soft tissue phenotype defined by the gingival thickness, keratinized tissue width, mucosal margin level and interproximal papilla height around implant.
Materials and Methods: 24 patients complaining of a single missing tooth in the with adjacent intact natural teeth and demanding replacing it with the best possible esthetics will be enrolled and recruited from the outpatient clinic, Faculty of Dentistry, Ain Shams University according to eligibility criteria. They will be randomly allocated to two equal groups. Group A (test group, n=12) will have a single implant placed after receiving non-surgical periodontal therapy and then after 12 weeks at the uncovering of the implant and placement of healing abutment, an Omega roll envelope flap (OREF) technique will be carried out for soft tissue augmentation, while Group B (control group, n=12) same procedures will be done but, soft tissue augmentation will be done by an envelope split-thickness flap combined with a sub-epithelial connective tissue graft. After 3 and 6 months Peri-implant soft tissue phenotype defined by gingival thickness, keratinized tissue width, mucosal margin level and interproximal papilla height around implant will be clinically assessed (1ry outcome). The 2ry outcomes will include comparing between the probing depth and clinical attachment level. Postoperative pain and swelling will be recorded by the patient for the 1st two weeks post-surgically. Postoperative instructions and medication will be given to the patient. All readings will be carried out by a calibrated outcome assessor who will be blinded. Data collected will be tabulated and statistically analyzed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
Soft tissue augmentation around dental implants using Omega roll envelope flap (OREF) technique.
Peri-implant soft tissue phenotype
Measured in millimeters, using UNC-15 Periodontal Probe/Endodontic File with rubber stopper,
Time frame: Baseline, 3 Months & 6 Months
Postoperative pain
Numerical rating scale (Visual analog scale) Scores (0-10)
Time frame: At the day of the procedure and for 14 days (registered before bedtime at a specific time point for each patient)
Postoperative swelling
Numerical rating scale (Visual analog scale) Scores (0-10)
Time frame: At the day of procedure and for 7 days (registered before bedtime at specific time point for each patient)
Implant soft tissue deficiency Esthetic Score (IDES)
Scores of: * Soft Tissue Margin (STM) (0-5): 0= No improvement of the PSTD and 5=Complete coverage of the metallic components with the mucosal margin at the same level of the homologous tooth. * Peri-implant papillae height (PPH) (0-3): 0=Both papillae are more apical than the healthiest papilla tip of the homologous tooth and 3=Both papillae are at the same level (or more coronal) of the healthiest papilla tip of the homologous tooth. * Peri-implant Mucosa (PMC) (0-1): 0=Distinguishable from the adjacent soft tissue and 1=Not distinguishable from the adjacent soft tissue. * Peri-implant Mucosa Appearance (PMA) (0-1): 0=Presence of at least one of these conditions: scar tissue, MGJ not-aligned, tissue volume too thin or too thick compared to the adjacent soft tissue or tissue texture not similar to the adjacent soft tissue and 1=Absence of scar tissue, MGJ well aligned, tissue volume in line with the adjacent soft tissue or tissue texture similar to the adjacent soft tissue.
Time frame: At 6 months
Esthetic satisfaction
Numerical rating scale (Visual analog scale) Scores (0-10)
Time frame: At 3 and 6 months
Probing depth
Using UNC-15 Periodontal Probe
Time frame: Baseline, 3 Months & 6 Months
Clinical Attachment Level (CAL)
Using UNC-15 Periodontal Probe 0mm= Normal \<1-2mm= Stage 1 Periodontitis \<3-4mm= Stage 2 Periodontitis \>5mm= Stage 3 and 4 Perodontitis
Time frame: Baseline, 3 Months & 6 Months
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