A Phase 1 interventional study of Sandwich technique with xenograft, collagen membrane and simultaneous implant placement. and Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement. in Alveolar Bone Resorption, sponsored by Al-Azhar University. Active, not recruiting at 1 site in Egypt. Open to participants aged 30 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-06-19.
Sponsored by Al-Azhar University · Phase 1, Interventional, and Other
Researcher will introduce the trial to patients and provide full explanation of its aim and benefits in Arabic language. Patients will then be able to have an informed discussion with the researcher. Researcher will obtain written consent from patients willing to participate in the trial
This protocol and the template informed consent form will be reviewed by the Ethics Committee of Scientific Research -Faculty of Oral and Dental Medicine- Al-Azhar University.
167 studies on the registry are indexed under Bone Resorption; 28 are open to participants now.
This study's planned enrollment of 12 is below the median of 24 across 146 interventional studies indexed under Bone Resorption.
Browse Bone Resorption studies →Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
(Control group) will receive computer-guided sandwich osteotomy technique with xenograft, collagen membrane and simultaneous implant placement.
Procedure: Sandwich technique with xenograft, collagen membrane and simultaneous implant placement.
(Study group) will receive computer-guided sandwich osteotomy technique with (RGD), xenograft, collagen membrane and simultaneous implant placement.
Biological: Sandwich technique with (RGD), xenograft, collagen membrane and simultaneous implant placement.
All surgery will be in upper arch, for sandwich osteotomy technique, after local anesthesia, crestal incision with buccal intrasulcular incisions will be done extending at least one tooth mesial and distal to the implant associated site. Full thickness mucoperiosteal flaps will be reflected to allow access for implant, distraction osteogenesis, xenograft. Osteotomy for implant will be carried out with advanced kit of roott_system Switzerland brand, sandwich osteotomy technique will be carried out with three full thickness cuts using the tungsten carbide disc were performed in the form of two vertical cuts away from the neighboring teeth by 3 mm and one horizontal bony cut on the labial surface of alveolar ridge. Bone splitting chisels were used in sequential width (2 mm, 3 mm) and lightweight mallet to complete splitting of the bony segment, the surgical sites will be irrigated with sterile saline. Surgical flaps will be sutured to the pre-surgical level.
All surgery will be in upper arch, for sandwich osteotomy technique, after local anesthesia, crestal incision with buccal intrasulcular incisions will be done extending at least one tooth mesial and distal to the implant associated site. Full thickness mucoperiosteal flaps will be reflected to allow access for implant, distraction osteogenesis, xenograft with and with RGD. Injectable RGD-bioconjugate Mussel Adhesive Proteins (RGD-MAPs) composite hydroxypropyl methylcellulose (HPMC) hydrogels . Previously we developed a novel type of injectable self-supported hydrogel (2 mg/ml of RGD-MAPs/HPMC) based porcine nano hydroxyapatite (MPH) for dental graft, which could good handling property, biodegradation or biocompatibility with the hydrogel disassembly and provided efficient cell adhesion activity and no inflammatory responses. Surgical flaps will be sutured to the pre-surgical level with 4-0 polyproline non resorbable suture utilizing a single interrupted suturing technique.
Effect of RGD on volumetric bone changes
Cone beam computed tomography with minimal field of view was taken immediately after surgery, immediately before loading (6 months) and 6 months after loading to evaluate volumetric changes.
Time frame: Preoperative Cone beam computed tomography (CBCT) with minimal field of view will be taken for (implant treatment plan), immediately after surgery, at time of loading and 6 months after loading.
Plan to share: No
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This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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