An interventional study of Control Arm (Allograft + Collagen Membrane) and Study Arm (Hydrogel-enhanced Allograft + Collagen membrane) in Alveolar Ridge Atrophy, sponsored by Damascus University. Not yet recruiting. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
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.
Horizontal alveolar ridge deficiency is a common anatomical limitation for implant placement and may require augmentation before implant rehabilitation. The biological and volumetric performance of the grafting material is an important determinant of the predictability of ridge reconstruction. This study is designed to investigate whether incorporation of a hydrogel component into a human allograft can enhance the outcome of horizontal ridge augmentation compared with a conventional particulate allograft approach.
The study will prospectively compare the two grafting strategies under otherwise standardized clinical conditions. The principal comparison will focus on the dimensional reconstruction of the deficient ridge following the healing period, with particular emphasis on the horizontal bone gain achieved at 6 months. Radiographic and clinical assessments will be used to characterize the augmentation outcome and to evaluate the consistency and clinical feasibility of the two approaches.
The findings are intended to provide clinical evidence regarding whether hydrogel enhancement of an allogeneic graft offers an advantage over a conventional allograft when used for horizontal reconstruction of severely narrow mandibular ridges.
Damascus University is the lead sponsor of 207 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants randomized to the control arm will undergo horizontal alveolar ridge augmentation using a standard particulate human allograft in combination with a resorbable collagen membrane. The graft will be prepared and applied according to the standardized surgical protocol, followed by membrane adaptation and tension-free primary wound closure. This arm represents the conventional allograft-based augmentation approach against which the hydrogel-enhanced graft will be compared.
Procedure: Control Arm (Allograft + Collagen Membrane)
Participants randomized to the study arm will undergo horizontal alveolar ridge augmentation using a hydrogel-enhanced human allograft in combination with the same type of resorbable collagen membrane used in the control arm. The hydrogel-enhanced graft will be prepared according to the manufacturer's instructions and applied using the same standardized surgical principles as the control arm. This arm is intended to determine whether hydrogel enhancement provides superior horizontal ridge reconstruction compared with the standard allograft approach.
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 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\*
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.
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)
• 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).
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)
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).
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.
Oral health-related quality of life
Measurement Method: Oral Health-Related Quality of Life (OHIP-14) Score. Definition: Oral health-related quality of life will be assessed using the validated 14-item Oral Health Impact Profile questionnaire (OHIP-14). The questionnaire will be self-administered at each assessment time point. Total scores range from 0 to 56, with higher scores indicating a greater negative impact of oral health on quality of life.
Time frame: Baseline (before the augmentation procedure), 6 months after the augmentation procedure, and 3 months after implant placementز
VAS pain scores
Measurement Method: Daily pain diary (0-100 mm VAS). Definition: Patient self-reported pain intensity on 0-100 mm VAS; daily recording at the same time each day; area under the curve (AUC) and peak pain score analyzed.
Time frame: Days 1-7 post-op.
Implant placement feasibility
Measurement Method: CBCT measurement + clinical assessment. Definition: Binary: Yes/No - sufficient ridge width ≥6 mm at 3 mm below crest for placement of a standard-diameter (3.75-4.0 mm) implant.
Time frame: 6 months after augmentation (T2)
Need for Additional Bone Augmentation Before Implant Placement
Measurement Method: CBCT measurement + clinical assessment. Definition: The need for additional bone augmentation before dental implant placement will be assessed clinically and radiographically at the 6-month follow-up. Each treatment site will be classified according to whether additional augmentation is required to achieve adequate hard-tissue dimensions for implant placement. The outcome will be recorded as Yes/No, indicating whether additional bone augmentation is required.
Time frame: 6 months after augmentation (T2)
Wound healing quality
Measurement Method: Modified Landry Wound Healing Index. Definition: 5-point scale (1 = very poor to 5 = excellent) assessing tissue color, bleeding, suppuration, epithelialization, and granulation tissue.
Time frame: Days 7, 14, 3 Week, Week 4.
Soft tissue complications
Measurement Method: Clinical measurement. Definition: Dehiscence size (mm, greatest dimension), membrane exposure timing (days post-op) and extent (mm²), time to secondary closure (days).
Time frame: From the day of the augmentation procedure through 6 months after surgery
No study locations are listed for this record.
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Damascus University