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NCT07865299

HydroGraft for Mandibular Horizontal Ridge Atrophy Augmentation.

Sponsor: Damascus University

View on ClinicalTrials.gov

Summary

This randomized controlled trial aims to evaluate the efficacy of a hydrogel-enhanced allograft compared with a standard particulate allograft, both used in conjunction with a resorbable collagen membrane, for horizontal alveolar ridge augmentation in patients with mandibular Cawood and Howell Class IV ridge defects. The primary objective is to determine whether the hydrogel-enhanced allograft results in greater horizontal bone gain at 6 months following augmentation.

Official title: Efficacy of Hydrogel-Enhanced Allograft Versus Standard Allograft With Collagen Membrane for Horizontal Ridge Augmentation in Mandibular Cawood-Howell Class IV Defects: A Two-Arm, Parallel-Group, Superiority Randomized Controlled Trial.

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09-28

Completion Date

2027-06-17

Last Updated

2026-10-08

Healthy Volunteers

Conditions

Alveolar Ridge Atrophy

Interventions

PROCEDURE

Control Arm (Allograft + Collagen Membrane)

Following local anesthesia, a mid-crestal incision with intrasulcular extensions around the adjacent teeth is made, followed by full-thickness flap elevation and buccal cortical decortication using a small round bur. Particulate allograft is then hydrated with sterile saline according to the manufacturer's instructions for 5-10 minutes and packed against the decorticated buccal surface to the desired contour, with 20-25% overaugmentation to compensate for anticipated resorption. A resorbable collagen membrane is adapted to extend 2-3 mm beyond the graft margins on all sides, followed by tension-free flap closure\*

PROCEDURE

Study Arm (Hydrogel-enhanced Allograft + Collagen membrane)

Following local anesthesia, a mid-crestal incision with intrasulcular extensions around the adjacent teeth is made, followed by full-thickness flap elevation and buccal cortical decortication using small round bur. S1 Dental granules are prepared according to the manufacturer's Quick Guide by hydration with the recommended saline volume and kneading for at least 30 seconds until a lumpy, viscous consistency is achieved. The composite graft is then packed against the decorticated buccal surface to the desired contour, with 20-25% overaugmentation to compensate for anticipated resorption. A resorbable collagen membrane is adapted to extend 2-3 mm beyond the graft margins on all sides, followed by tension-free flap closure.

Inclusion Criteria: 1. Adults aged ≥18 years at the time of enrollment. 2. Cawood and Howell Class IV mandibular horizontal ridge atrophy (knife-edge ridge with sufficient height but inadequate width) at the anterior region. 3. Residual alveolar ridge width ≤ 4 mm measured on baseline CBCT at 3 mm below the alveolar crest at the planned augmentation site. 4. Adequate ridge height for planned implant length (≥ 10 mm from crest to vital structures or lower mandibular border). 5. ASA Physical Status Classification I or II. 6. Non-smoker, or former smoker who has quit ≥ 6 months prior to enrollment (verified by patient self-report). 7. Willingness to comply with the study protocol and attend all scheduled follow-up visits for the 6-month study duration. 8. Able to read, understand, and provide written informed consent in the language of the study site. Exclusion Criteria: 1. Uncontrolled systemic disease, including but not limited to: uncontrolled diabetes mellitus (HbA1c \>7.5% within 3 months of enrollment), uncontrolled hypertension, autoimmune disorders requiring immunosuppressive therapy. 2. Current smokers, or users of tobacco, e-cigarettes, smokeless tobacco, or other nicotine delivery products. 3. History of radiation therapy to the head and neck region. 4. Current or past (within 3 years) use of bisphosphonate therapy (oral or intravenous) or other antiresorptive/antiangiogenic agents (denosumab, bevacizumab). 5. Pregnancy or lactation at the time of enrollment, or planned pregnancy during the study period. 6. Active periodontal disease (untreated) at any site in the mouth; patients may be enrolled after completion of periodontal treatment and demonstration of disease stability. 7. Known allergy or hypersensitivity to collagen, or any component of the graft materials used in the study. 8. Previous bone augmentation procedure (GBR, block graft) at the planned study site. 9. Clinical or radiographic indication for simultaneous vertical ridge augmentation at the study site. 10. Inadequate oral hygiene: full-mouth plaque score \>25% after completion of the pre-surgical hygiene phase. 11. History of alcohol abuse or substance use disorder (per DSM-5 criteria) within the past 12 months.

Clinical Research Directory

HydroGraft for Mandibular Horizontal Ridge Atrophy Augmentation.

Summary

Key Details

Conditions

Interventions

Eligibility Criteria