Guided Bone Regeneration Clinical Trial
Official title:
Evaluation of Double Layer Graft Technique for Horizontal Ridge Augmentation With Staged Implant Placement (A Randomized Controlled Clinical Trial With Histological Assessment)
NCT number | NCT06139939 |
Other study ID # | 112 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 6, 2021 |
Est. completion date | August 30, 2023 |
Verified date | November 2023 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
clinical study with guided bone regeneration for deficient alveolar ridge to restore the defect in width and be able to place implant with two different technique
Status | Completed |
Enrollment | 18 |
Est. completion date | August 30, 2023 |
Est. primary completion date | May 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 40 Years |
Eligibility | Inclusion Criteria: - 1- Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire. (American Society of Anesthesiologists I; ASA I) (Mombelli and Cionca, 2006) 2- Both genders. 3- Age from 20 - 40 years old. 4- Having missing maxillary or mandibular tooth with low or moderate horizontal defect (4-8) according to cologne classification (2013) 5- Presence of sufficient bone height minimum 12 mm that does not require bone grafting or any other ridge augmentation procedure.(Shah and Lum, 2008) 6- Presence of sufficient keratinized mucosa of at least 2 mm.(Bassetti, et al. 2015) Exclusion Criteria: - 1- Smokers (Twito and Sade, 2014) 2- Vulnerable groups (as pregnant females and decisional impaired individuals) will be excluded from the study. 3- Patients with poor oral hygiene or not willing to perform oral hygiene measures. 4- Prisoners and handicapped patients. 5- Patients with periodontal or periapical infections.(Tonetti, et al. 1996) |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain shams university , faculty of dentistry | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinical and radiographic outcome | clinical ridge width gain | 6 months | |
Secondary | histological analysis of remodeled bone. | core biopsy were taken after 6 months from augmentation | 6 months |
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