[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659446":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":63,"studyPopulation":53,"armGroups":64,"interventions":77,"overallOfficials":53,"centralContacts":86,"locations":53,"responsibleParty":96,"collaborators":53,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":53,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":53,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":122,"whyStopped":53,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":53},{"fullName":5,"class":6},"Damascus University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":53},[9],{"measure":10,"description":11,"timeFrame":12},"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","Baseline (T0) and 6 months after horizontal ridge augmentation (T2)",[14,18,22,26,30,34,38,42,45,49],{"measure":15,"description":16,"timeFrame":17},"• 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","T1 (immediately after the surgery), T2 (6 months post-augmentation).",{"measure":19,"description":20,"timeFrame":21},"Bone density","Measurement Method: CBCT grey values \u002F Hounsfield units. Definition: Mean grey value \u002F HU within a standardized region of interest (ROI) at the center of the grafted region on cross-sectional CBCT.","T0 (Baseline, before the surgery), T1 (immediately after the surgery), T2 (6 months post-augmentation)",{"measure":23,"description":24,"timeFrame":25},"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.","Immediately after augmentation (T1) and 6 months after augmentation (T2).",{"measure":27,"description":28,"timeFrame":29},"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).","From the day of the augmentation procedure through 6 months after surgery.",{"measure":31,"description":32,"timeFrame":33},"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.","Baseline (before the augmentation procedure), 6 months after the augmentation procedure, and 3 months after implant placementز",{"measure":35,"description":36,"timeFrame":37},"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.","Days 1-7 post-op.",{"measure":39,"description":40,"timeFrame":41},"Implant placement feasibility","Measurement Method: CBCT measurement + clinical assessment. Definition: Binary: Yes\u002FNo - sufficient ridge width ≥6 mm at 3 mm below crest for placement of a standard-diameter (3.75-4.0 mm) implant.","6 months after augmentation (T2)",{"measure":43,"description":44,"timeFrame":41},"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\u002FNo, indicating whether additional bone augmentation is required.",{"measure":46,"description":47,"timeFrame":48},"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.","Days 7, 14, 3 Week, Week 4.",{"measure":50,"description":51,"timeFrame":52},"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).","From the day of the augmentation procedure through 6 months after surgery",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":53,"primaryPurpose":57,"observationalModel":53,"timePerspective":53,"maskingInfo":58},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":59,"maskingDescription":60,"whoMasked":61},"SINGLE","The study will use assessor masking. The surgeon performing the augmentation procedure cannot be masked because the two grafting materials differ in their preparation and handling characteristics. Participants will not be routinely informed of the specific graft allocation beyond the information required for informed consent. Outcome assessments, including radiographic measurements of horizontal ridge dimensions, will be performed by an examiner who is blinded to treatment-group allocation.",[62],"OUTCOMES_ASSESSOR","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.\n\nThe 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.\n\nThe 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.",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"Control Arm (Allograft + Collagen Membrane)","ACTIVE_COMPARATOR","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.",[70],"Procedure: Control Arm (Allograft + Collagen Membrane)",{"label":72,"type":73,"description":74,"interventionNames":75},"Test Arm (Hydrogel-enhanced Allograft + Collagen membrane)","EXPERIMENTAL","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.",[76],"Procedure: Study Arm (Hydrogel-enhanced Allograft + Collagen membrane)",[78,82],{"type":79,"name":66,"description":80,"armGroupLabels":81,"otherNames":53},"PROCEDURE","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\\*",[66],{"type":79,"name":83,"description":84,"armGroupLabels":85,"otherNames":53},"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.",[72],[87,92],{"name":88,"role":89,"phone":90,"phoneExt":53,"email":91},"Rabee Alnaddaf, DDS, MSc student","CONTACT","+963 966 434 343","rabeenadaf6@gmail.com",{"name":93,"role":89,"phone":94,"phoneExt":53,"email":95},"Tarek Qassim, DDS, MSc, PhD","+963 981 555 778","tareqkaseem70@gmail.com",{"type":97,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR","100659446","hydrograft-for-mandibular-horizontal-ridge-atrophy-augmentation-100659446",false,"NCT07865299","HydroGraft for Mandibular Horizontal Ridge Atrophy Augmentation.","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.","Inclusion Criteria:\n\n1. Adults aged ≥18 years at the time of enrollment.\n2. Cawood and Howell Class IV mandibular horizontal ridge atrophy (knife-edge ridge with sufficient height but inadequate width) at the anterior region.\n3. Residual alveolar ridge width ≤ 4 mm measured on baseline CBCT at 3 mm below the alveolar crest at the planned augmentation site.\n4. Adequate ridge height for planned implant length (≥ 10 mm from crest to vital structures or lower mandibular border).\n5. ASA Physical Status Classification I or II.\n6. Non-smoker, or former smoker who has quit ≥ 6 months prior to enrollment (verified by patient self-report).\n7. Willingness to comply with the study protocol and attend all scheduled follow-up visits for the 6-month study duration.\n8. Able to read, understand, and provide written informed consent in the language of the study site.\n\nExclusion Criteria:\n\n1. 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.\n2. Current smokers, or users of tobacco, e-cigarettes, smokeless tobacco, or other nicotine delivery products.\n3. History of radiation therapy to the head and neck region.\n4. Current or past (within 3 years) use of bisphosphonate therapy (oral or intravenous) or other antiresorptive\u002Fantiangiogenic agents (denosumab, bevacizumab).\n5. Pregnancy or lactation at the time of enrollment, or planned pregnancy during the study period.\n6. Active periodontal disease (untreated) at any site in the mouth; patients may be enrolled after completion of periodontal treatment and demonstration of disease stability.\n7. Known allergy or hypersensitivity to collagen, or any component of the graft materials used in the study.\n8. Previous bone augmentation procedure (GBR, block graft) at the planned study site.\n9. Clinical or radiographic indication for simultaneous vertical ridge augmentation at the study site.\n10. Inadequate oral hygiene: full-mouth plaque score \\>25% after completion of the pre-surgical hygiene phase.\n11. History of alcohol abuse or substance use disorder (per DSM-5 criteria) within the past 12 months.","ALL","18 Years","50 Years",{"count":109,"type":110},18,"ESTIMATED","INTERVENTIONAL",[113],"NA","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.",[116],"Alveolar Ridge Atrophy",[118,119,120,121],"Alveolar Ridge Augmentation","HydroGraft","Allograft","Collagen Membrane","NOT_YET_RECRUITING","2026-10-03",{"date":125,"type":126},"2026-10-08","ACTUAL",{"date":128,"type":110},"2026-09-28",{"date":130,"type":110},"2027-06-17",{"name":5,"class":6}]