Dental Implants Clinical Trial
Official title:
Evaluation of Omega Roll Envelope Flap for Soft Tissue Augmentation Around Osseointegrated Dental Implants
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.
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | May 1, 2025 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Systemically free patients (American Society of Anesthesiologists (ASA) I. Patients between 18 - 50 years of both genders and able to understand the nature of the proposed surgery and to sign the informed consent. Ability to comply with the study related procedures such as maintaining good oral hygiene and attending all follow-up scheduled appointments. Patients who complained of a single missing tooth bounded with two adjacent natural sound teeth diagnosed with clinical periodontal health. Necessity for soft tissue augmentation in a single tooth gap determined by a concavity that was present in the edentulous area or tissues with thin biotype being =2 mm or with inadequate width of =4mm. Adequate bone width for implant placement without need for bone augmentation (confirmed by a single pre-operative cone-beam computed tomography) (CBCT). Exclusion Criteria: - Previous soft tissue augmentation in the area. Need for major soft or hard tissue augmentation procedures. Smokers. Patients taking medications that might affect the healing of soft and hard peri-implant tissues. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Ain Shams University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peri-implant soft tissue phenotype | Measured in millimeters, using UNC-15 Periodontal Probe/Endodontic File with rubber stopper, | Baseline, 3 Months & 6 Months | |
Secondary | Postoperative pain | Numerical rating scale (Visual analog scale) Scores (0-10) | At the day of the procedure and for 14 days (registered before bedtime at a specific time point for each patient) | |
Secondary | Postoperative swelling | Numerical rating scale (Visual analog scale) Scores (0-10) | At the day of procedure and for 7 days (registered before bedtime at specific time point for each patient) | |
Secondary | 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. |
At 6 months | |
Secondary | Esthetic satisfaction | Numerical rating scale (Visual analog scale) Scores (0-10) | At 3 and 6 months | |
Secondary | Probing depth | Using UNC-15 Periodontal Probe | Baseline, 3 Months & 6 Months | |
Secondary | 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 | Baseline, 3 Months & 6 Months |
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