Alveolar Ridge AtrophyNCT07865299
HydroGraft for Mandibular Horizontal Ridge Atrophy Augmentation.
A study testing Study Arm (Hydrogel-enhanced Allograft + Collagen membrane) in people with Alveolar Ridge Atrophy, run by Damascus University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Alveolar Ridge Atrophy
- What is being tested?
- Study Arm (Hydrogel-enhanced Allograft + Collagen membrane)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2026to 17 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
- ASA Physical Status Classification I or II.
- Non-smoker, or former smoker who has quit ≥ 6 months prior to enrollment (verified by patient self-report).
- Willingness to comply with the study protocol and attend all scheduled follow-up visits for the 6-month study duration.
- Able to read, understand, and provide written informed consent in the language of the study site.
Who cannot join
- 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).
- Pregnancy or lactation at the time of enrollment, or planned pregnancy during the study period.
- Active periodontal disease (untreated) at any site in the mouth; patients may be enrolled after completion of periodontal treatment and demonstration of disease stability.
Show all 11Show fewer
- Known allergy or hypersensitivity to collagen, or any component of the graft materials used in the study.
- Previous bone augmentation procedure (GBR, block graft) at the planned study site.
- Clinical or radiographic indication for simultaneous vertical ridge augmentation at the study site.
- Inadequate oral hygiene: full-mouth plaque score >25% after completion of the pre-surgical hygiene phase.
- History of alcohol abuse or substance use disorder (per DSM-5 criteria) within the past 12 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
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.
Read the detailed description
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.
- Conditions
- Alveolar Ridge Atrophy
- Being tested
- Control Arm (Allograft + Collagen Membrane), Study Arm (Hydrogel-enhanced Allograft + Collagen membrane)
- Keywords
- Alveolar Ridge Augmentation, HydroGraft, Allograft, Collagen Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Arm (Allograft + Collagen Membrane)Procedure or 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 or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Control Arm (Allograft + Collagen Membrane) |
| 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. Receives: Procedure: Study Arm (Hydrogel-enhanced Allograft + Collagen membrane) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (T0) and 6 months after horizontal ridge augmentation (T2)
Secondary outcomes (10)
• 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: From the day of the augmentation procedure through 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start28 Sep 2026 (estimated)
- Primary completion28 Apr 2027 (estimated)
- Study completion17 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alveolar Ridge AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865299
- Sponsor's protocol ID
- UDDS-Perio-11-2026
- Status last verified
- Oct 2026
- First submitted
- 19 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Serrano Mendez CA, Lang NP, Caneva M, Ramirez Lemus G, Mora Solano G, Botticelli D. Comparison of allografts and xenografts used for alveolar ridge preservation. A clinical and histomorphometric RCT in humans. Clin Implant Dent Relat Res. 2017 Aug;19(4):608-615. doi: 10.1111/cid.12490. Epub 2017 May 2.
PubMed 28466494de Azambuja Carvalho PH, Dos Santos Trento G, Moura LB, Cunha G, Gabrielli MAC, Pereira-Filho VA. Horizontal ridge augmentation using xenogenous bone graft-systematic review. Oral Maxillofac Surg. 2019 Sep;23(3):271-279. doi: 10.1007/s10006-019-00777-y. Epub 2019 May 15.
PubMed 31089897Tony JB, Parthasarathy H, Tadepalli A, Ponnaiyan D, Alamoudi A, Kamil MA, Alzahrani KJ, Alsharif KF, Halawani IF, Alnfiai MM, Ramachandran L, Balaji TM, Patil S. CBCT Evaluation of Sticky Bone in Horizontal Ridge Augmentation with and without Collagen Membrane-A Randomized Parallel Arm Clinical Trial. J Funct Biomater. 2022 Oct 19;13(4):194. doi: 10.3390/jfb13040194.
PubMed 36278663El Rassi C, Chakar C, Menassa G, Saleh A, Samarani R. Lateral ridge augmentation using autogenous-xenogenic or allogenic-xenogenic graft mix with a cross-linked collagen membrane: a randomized pilot clinical trial. J Stomatol Oral Maxillofac Surg. 2025 Oct;126(5S):102442. doi: 10.1016/j.jormas.2025.102442. Epub 2025 Jun 26.
PubMed 40581308Geurs NC, Korostoff JM, Vassilopoulos PJ, Kang TH, Jeffcoat M, Kellar R, Reddy MS. Clinical and histologic assessment of lateral alveolar ridge augmentation using a synthetic long-term bioabsorbable membrane and an allograft. J Periodontol. 2008 Jul;79(7):1133-40. doi: 10.1902/jop.2008.070595.
PubMed 18597594
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07865299
- Acronym / sponsor ID
- UDDS-Perio-11-2026
- Conditions
- Alveolar Ridge Atrophy
- Keywords
- Alveolar Ridge Augmentation, HydroGraft, Allograft, Collagen Membrane
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 28 Apr 2027 (estimated)
- Study completion
- 17 Jun 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm (Allograft + Collagen Membrane) | Active comparator | Procedure: Control Arm (Allograft + Collagen Membrane)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. |
| Test Arm (Hydrogel-enhanced Allograft + Collagen membrane) | Experimental | Procedure: Study Arm (Hydrogel-enhanced 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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).
- ASA Physical Status Classification I or II.
Key exclusion criteria (11 listed)
- 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).
- Pregnancy or lactation at the time of enrollment, or planned pregnancy during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Control Arm (Allograft + Collagen Membrane) |
| 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. | Procedure or surgery | Test Arm (Hydrogel-enhanced Allograft + Collagen membrane) |
Primary outcome
Horizontal bone width gain
Time frame: Baseline (T0) and 6 months after horizontal ridge augmentation (T2)
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
10 secondary outcomes
• Graft volumetric change
Time frame: T1 (immediately after the surgery), T2 (6 months post-augmentation).
Bone density
Time frame: T0 (Baseline, before the surgery), T1 (immediately after the surgery), T2 (6 months post-augmentation)
Graft resorption rate
Time frame: Immediately after augmentation (T1) and 6 months after augmentation (T2).
Complication rate
Time frame: From the day of the augmentation procedure through 6 months after surgery.
Oral health-related 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
Time frame: Days 1-7 post-op.
Implant placement feasibility
Time frame: 6 months after augmentation (T2)
Need for Additional Bone Augmentation Before Implant Placement
Time frame: 6 months after augmentation (T2)
Wound healing quality
Time frame: Days 7, 14, 3 Week, Week 4.
Soft tissue complications
Time frame: From the day of the augmentation procedure through 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Results publication: PubMed 28466494Serrano Mendez CA, Lang NP, Caneva M, Ramirez Lemus G, Mora Solano G, Botticelli D. Comparison of allografts and xenografts used for alveolar ridge preservation. A clinical and histomorphometric RCT in humans. Clin Implant Dent Relat Res. 2017 Aug;19(4):608-615. doi: 10.1111/cid.12490. Epub 2017 May 2.
- Results publication: PubMed 31089897de Azambuja Carvalho PH, Dos Santos Trento G, Moura LB, Cunha G, Gabrielli MAC, Pereira-Filho VA. Horizontal ridge augmentation using xenogenous bone graft-systematic review. Oral Maxillofac Surg. 2019 Sep;23(3):271-279. doi: 10.1007/s10006-019-00777-y. Epub 2019 May 15.
- Results publication: PubMed 36278663Tony JB, Parthasarathy H, Tadepalli A, Ponnaiyan D, Alamoudi A, Kamil MA, Alzahrani KJ, Alsharif KF, Halawani IF, Alnfiai MM, Ramachandran L, Balaji TM, Patil S. CBCT Evaluation of Sticky Bone in Horizontal Ridge Augmentation with and without Collagen Membrane-A Randomized Parallel Arm Clinical Trial. J Funct Biomater. 2022 Oct 19;13(4):194. doi: 10.3390/jfb13040194.
- Results publication: PubMed 40581308El Rassi C, Chakar C, Menassa G, Saleh A, Samarani R. Lateral ridge augmentation using autogenous-xenogenic or allogenic-xenogenic graft mix with a cross-linked collagen membrane: a randomized pilot clinical trial. J Stomatol Oral Maxillofac Surg. 2025 Oct;126(5S):102442. doi: 10.1016/j.jormas.2025.102442. Epub 2025 Jun 26.
- Results publication: PubMed 18597594Geurs NC, Korostoff JM, Vassilopoulos PJ, Kang TH, Jeffcoat M, Kellar R, Reddy MS. Clinical and histologic assessment of lateral alveolar ridge augmentation using a synthetic long-term bioabsorbable membrane and an allograft. J Periodontol. 2008 Jul;79(7):1133-40. doi: 10.1902/jop.2008.070595.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Study Arm (Hydrogel-enhanced Allograft + Collagen membrane) in people with Alveolar Ridge Atrophy, run by Damascus University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rabee Alnaddaf, DDS, MSc student (+963 966 434 343, rabeenadaf6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal bone width gain (time frame: Baseline (T0) and 6 months after horizontal ridge augmentation (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07865299, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.