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Completed

NCT Number: NCT06139939

Guided Bone Regeneration for Horizontal Alveolar Ridge Augmentation With Double Layer Technique

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

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Key information

Conditions

Guided Bone Regeneration

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams university , faculty of dentistry

Cairo, 4543070, Egypt

About this study

This study will be conducted to compare the bone formation with double layer graft technique versus standard protocol in GBR for horizontal ridge augmentation with staged implant placement

Primary outcome: Evaluation of alveolar bone width gain clinically and radiographically.

Secondary outcome: Histological analysis of remodeled bone.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Double layer technique

Procedure

Double layer technique for alveolar ridge augmentation (first layer autograft followed by xenograft second layer).

Primary outcomes

  1. clinical and radiographic outcome

    Time frame: 6 months

    clinical ridge width gain

Secondary outcomes

  1. histological analysis of remodeled bone.

    Time frame: 6 months

    core biopsy were taken after 6 months from augmentation

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Evaluation of Double Layer Graft Technique for Horizontal Ridge Augmentation With Staged Implant Placement (A Randomized Controlled Clinical Trial With Histological Assessment)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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