Health TrialsbyHealthPanel

HydroGraft for Mandibular Horizontal Ridge Atrophy Augmentation.

ConditionAlveolar Ridge Atrophy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorDamascus University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged ≥18 years at the time of enrollment.

Cawood and Howell Class IV mandibular horizontal ridge atrophy (knife-edge ridge with sufficient height but inadequate width) at the anterior region.

Residual alveolar ridge width ≤ 4 mm measured on baseline CBCT at 3 mm below the alveolar crest at the planned augmentation site.

Adequate ridge height for planned implant length (≥ 10 mm from crest to vital structures or lower mandibular border).

Disqualifiers

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.

Current smokers, or users of tobacco, e-cigarettes, smokeless tobacco, or other nicotine delivery products.

History of radiation therapy to the head and neck region.

Current or past (within 3 years) use of bisphosphonate therapy (oral or intravenous) or other antiresorptive/antiangiogenic agents (denosumab, bevacizumab).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Control Arm (Allograft + Collagen Membrane)

    Procedure/Surgery

    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\*

  • Study Arm (Hydrogel-enhanced Allograft + Collagen membrane)

    Procedure/Surgery

    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.

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: Control Arm (Allograft + Collagen Membrane)Active comparator 1 intervention
Group B: Test Arm (Hydrogel-enhanced Allograft + Collagen membrane)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Horizontal bone width gain

Horizontal ridge width will be assessed using CBCT at 1, 3, 5, and 7 mm below the alveolar crest. Measurements will be obtained at baseline and at 6 months after augmentation using standardized cross-sectional images. Horizontal bone gain will be calculated as the difference in buccolingual ridge width between T2 and T0, expressed in millimeters

Time frame
Baseline (T0) and 6 months after horizontal ridge augmentation (T2)

Secondary outcomes

1

• Graft volumetric change

Measurement Method: CBCT volumetric analysis (cm³). Total graft volume measured by semi-automatic threshold-based segmentation at T1 and T2; volumetric change = VT2 - VT1

Time frame
T1 (immediately after the surgery), T2 (6 months post-augmentation).
2

Bone density

Measurement Method: CBCT grey values / Hounsfield units. Definition: Mean grey value / HU within a standardized region of interest (ROI) at the center of the grafted region on cross-sectional CBCT.

Time frame
T0 (Baseline, before the surgery), T1 (immediately after the surgery), T2 (6 months post-augmentation)
3

Graft resorption rate

Measurement Method: CBCT volumetric analysis. Definition: Graft volume will be assessed using standardized CBCT volumetric analysis at T1 and T2. The percentage of graft volume reduction between the two time points will be calculated to determine the graft resorption rate.

Time frame
Immediately after augmentation (T1) and 6 months after augmentation (T2).
4

Complication rate

Measurement Method: Clinical assessment. Definition: Membrane exposure (graded per Urban classification), wound infection (clinical signs + purulence), wound dehiscence (mm), graft failure (complete loss requiring re-grafting), paresthesia (self-reported).

Time frame
From the day of the augmentation procedure through 6 months after surgery.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Damascus University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: