Guided Bone Regeneration for Horizontal Alveolar Ridge Augmentation With Double Layer Technique
Evaluation of Double Layer Graft Technique for Horizontal Ridge Augmentation With Staged Implant Placement (A Randomized Controlled Clinical Trial With Histological Assessment)
1 other identifier
interventional
18
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2023
CompletedFirst Submitted
Initial submission to the registry
November 15, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedNovember 18, 2023
November 1, 2023
2.1 years
November 15, 2023
November 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
clinical and radiographic outcome
clinical ridge width gain
6 months
Secondary Outcomes (1)
histological analysis of remodeled bone.
6 months
Study Arms (2)
double layer technique
EXPERIMENTALinclude 9 patients will receive lateral alveolar ridge augmentation with double bone graft layer technique for GBR (first layer autograft followed by xenograft second layer
control
OTHERinclude 9 patients will receive lateral alveolar ridge augmentation with stander protocol for GBR technique (mixture of autograft and xenograft
Interventions
Double layer technique for alveolar ridge augmentation (first layer autograft followed by xenograft second layer).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Smokers (Twito and Sade, 2014) 2- Vulnerable groups (as pregnant females and decisional impaired individuals) will be excluded from the study.
- Patients with poor oral hygiene or not willing to perform oral hygiene measures.
- Prisoners and handicapped patients. 5- Patients with periodontal or periapical infections.(Tonetti, et al. 1996)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain shams university , faculty of dentistry
Cairo, 4543070, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecture
Study Record Dates
First Submitted
November 15, 2023
First Posted
November 18, 2023
Study Start
May 6, 2021
Primary Completion
May 30, 2023
Study Completion
August 30, 2023
Last Updated
November 18, 2023
Record last verified: 2023-11