Alveolar Ridge Augmentation Using Porous Polyethylene Membrane and Composite Allograft for Staged Implant Placement: A Prospective Clinical, Radiologic, Histomorphometric and Volumetric Study

Phase 2

Completed

• Conditions: Vertical single- tooth alveolar bone loss ranging 2 - 6 mmWith or without horizontal alveolar bone loss; vertical alveolar bone loss; horizontal alveolar bone loss

• Registration Number: TCTR20171010005
• Lead Sponsor: Khon Kaen University, Faculty of Dentistry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-10
• Study Completion: 2018-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Generally healthy adult patients (ASA â… , â…¡) ranging 20-65 years old;
Good oral hygiene and periodontal conditions (full-mouth plaque and bleeding score ≤ 25%);
Single-tooth vertical or combined alveolar defect in posterior mandible;
Alveolar bone defects ranging 2-6 mm below buccal cemento-enamel junction (CEJ) connection line of two adjacent teeth.
Narrow flat edentulous ridge leads to larger crown-implant ratio, unsatisfactory esthetics, unpredictable implant integration and long-term prognosis than normal ridge;
Available bone height smaller than implant length selected;

Exclusion Criteria

Severe systemic disorders that contraindicate oral surgeries;
History of head and neck malignancy and related chemoradiotherapy;
Long-term use of steroid or immunological therapy (≥ 6 months);
Severe osteoporosis (≥ 2 fragility fractures);
Oral / intravenous bisphosphonate therapy ≥ 5 years;
Pregnancy and lactation for female patients;
Interocclusal restoration height available < 4.0 mm at edentulous area;
Severe tempromandibular joint (TMJ) disorders and parafunctions;
Bone augmentation procedure at the same site within the past one year;
Additional soft tissue augmentation procedures at the same site within the past six months;
Active, acute mucosal, periodontal and skeletal lesions;
Heavy drinkers (≥ 1 drink / day for women or 2 drinks / day for men);
Heavy smokers (≥ 10 cigarettes / day).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DMB (distance from matrix to bone) 1. During GBR procedure; 2. 6 months after GBR periodontall probe (0.1 mm),Attachd Gingival Width (AGW) 1. During GBR procedure; 2. 6 months after GBR periodontal probe (0.1 mm),Horizontal Alveolar Width (HAW) 1. During GBR procedure; 2. 6 months after GBR periodontal probe (0.1 mm),Available Bone Height (ABH) 1. During GBR procedure; 2. 6 months after GBR CBCT (0.1 mm)

Secondary Outcome Measures

Name	Time	Method
Implant stability quotient (ISQ) 1.at implant placement; 2. 4 months after implant placement Resonance Frequency Analysis (Osstell ISQ),Mesial Implant Exposure (MIE): 1.at implant placement; 2. 4 months after implant placement periapical film,Distal Implant Exposure (DIE): 1.at implant placement; 2. 4 months after implant placement periapical film,Buccocclusal area (BOA) 1. baseline before GBR; 2 6 months after GBR intraoral scanning (3Shape),Buccoapical area (BAA) 1. baseline before GBR; 2 6 months after GBR intraoral scanning (3Shape),Lingocclusal area (LOA) 1. baseline before GBR; 2 6 months after GBR intraoral scanning (3Shape),Lingoapical area (LAA) 1. baseline before GBR; 2 6 months after GBR intraoral scanning (3Shape),New bone percent (NB%) 6 months after GBR histomorphometry,Allograft particle percent (AP%) 6 months after GBR histomorphometry,Marrow space percent (MS%) 6 months after GBR histomorphometry,Connective tissue percent (CT%) 6 months after GBR histomorphometry