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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06139939

Enrollment

Registered

2023-11-18

Start date

2021-05-06

Completion date

2023-08-30

Last updated

2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Guided Bone Regeneration

Keywords

sausage technique

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

Detailed description

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.

Interventions

PROCEDUREDouble layer technique

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 40 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
clinical and radiographic outcome	6 months	clinical ridge width gain

Secondary

Measure	Time frame	Description
histological analysis of remodeled bone.	6 months	core biopsy were taken after 6 months from augmentation

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026