Missing Maxillary Anterior TeethNCT03839615
Poly Tetra Fluro Ethylene vs Native Collagen Membrane for Gbr in Anterior Maxilla
A study testing guided bone regenerations in people with Missing Maxillary Anterior Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
evaluation of amount of bone gained in the anterior maxilla using collagen membranes vs ptfe membrane while using a 1:1 mix of xenograft and autogenous bone Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Missing Maxillary Anterior Teeth
- What is being tested?
- guided bone regenerations
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Feb 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- • Heavy smokers more than 20 cigarettes per day.(32)
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems.
- Disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia.
- Pregnant or nursing women.
- Patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis.
- Patient with previous history of radiotherapy.
Trial locations and contacts
1 site in 1 country.
mohamed atef, professor contact
About this study
Official title: Assessment Of Poly Tetra Fluro Ethylene Membrane Versus Native Collagen Membrane With Guided Bone Regeneration In Atrophic Anterior Maxilla Using (1:1) Of Autogenous Bone And Xenograft Mixture (Randomized Clinical Trial)
evaluation of amount of bone gained in the anterior maxilla using collagen membranes vs ptfe membrane while using a 1:1 mix of xenograft and autogenous bone
Read the detailed description
The alveolar bone is formed during tooth eruption, and consists of maxillary and mandibular components that shape and support the alveolar sockets. When teeth are lost, alveolar atrophy occurs, ultimately resulting in a short and narrow alveolar ridge . Such changes in the alveolar bone have a significant effect on prosthetic restoration planning, and are particularly important for areas with esthetic requirements, such as the maxillary incisors. Since preservation of the alveolar bone after extraction makes implant placement and prosthetic restoration easier in the edentulous jaw, alveolar ridge preservation and reconstruction methods using various bone graft materials together with resorbable and non-resorbable membranes have been introduced in order to minimize the loss of alveolar bone after extraction.
Investigations of changes in the alveolar bone after extraction have frequently been performed through clinical measurements and radiographic analysis. In particular, after the extraction of a tooth with fracture or severe periodontitis, the alveolar bone shows severe horizontal and vertical atrophy. The reduction in the width of the alveolar ridge is more notable in the horizontal direction than in the vertical direction, and the buccal wall of the alveolar bone has been reported to undergo greater vertical atrophy than the lingual wall. Changes in the width of the alveolar ridge after extraction occur in a relatively short time, decreasing most rapidly within the first six months after extraction, followed by continual, slow bone resorption over the course of the rest of the patient's life .
When a tooth has been lost, the extent of alveolar bone resorption is affected by a range of factors, including the number of extracted teeth and bone walls, the bone density, the extent of alveolar bone loss, infection, and the presence or absence of adjacent teeth.
Dental implant has become a predictable treatment option, with excellent long-term results. However, the success of implant therapy depends on the amount of bone volume at the insertion site.Unfavorable local conditions may provide insufficient bone volume that negatively affects the prognosis of dental implants. Cawood and Howell in 1988 ranked the atrophy degree of edentulous jaws in six classes. Particularly, atrophies within class IV, also known as "knife-edge" ridges, present a serious horizontal defect, making challenging the placement of regular implants.
Many techniques have been developed to regenerate atrophic alveolar jaws for the placement of dental implants, performed either in combination with graft procedures or in second stage surgery after a period of healing. For many years, bone blocks represented the gold standard to reconstruct the alveolar ridge bone defects. This technique requires to harvest a wide amount of bone to rebuild the atrophic crest.(20). For this reason, bone blocks were often harvested from extra-oral sites with an higher morbidity. Moreover some problems can occur when a combined defects (horizontal and vertical) need to be treated. Guided bone regeneration (GBR) has been proposed as a possible alternative for patients with severe horizontal bone atrophy, to overcome the drawback of bone blocks techniques. To protect and prevent the invasion of the clot by nonosteogenic cells, maintaining an adequate biological space for the regeneration of bone tissue, the use of both non-resorbable or resorbable membranes, in combination with autologous or heterologous particulate bone have been proposed. Particulated autogenous bone can be mixed with bone substitutes to add more osteogenic factors.
Guided bone regeneration or GBR, and guided tissue regeneration or GTR are dental surgical procedures that use barrier membranes to direct the growth of new bone and gingival tissue at sites with insufficient volumes or dimensions of bone or gingiva for proper function, esthetics or prosthetic restoration.
GBR is similar to guided tissue regeneration (GTR) but is focused on development of hard tissues in addition to the soft tissues of the periodontal attachment. At present, guided bone regeneration is predominantly applied in the oral cavity to support new hard tissue growth on an alveolar ridge to allow stable placement of dental implants.
The first application of barrier membranes in the mouth occurred in 1982. in the context of regeneration of periodontal tissues via GTR, as an alternative to resective surgical procedures to reduce pocket depths.Barrier membrane is utilized in GBR technique to cover the bone defect and create a secluded space, which prevents the connective tissue from growing into the space and facilitates the growth priority of bone tissue.
Several surgical techniques via GBR have been proposed regarding the tri-dimensional bone reconstruction of the severely resorbed maxilla, using different types of bone substitutes that have regenerative, osseoinductive or osseoconductive properties which is then packed into the bony defect and covered by resorbable membranes. In cases where augmentation materials used are autografts or allografts the bone density is quite low and resorption of the grafted site in these cases can reach up to 30% of original volume. For higher predictability, nonresorbable titanium-reinforced d-polytetrafluoroethylene (d-PTFE) membranes-as a barrier against the migration of epithelial cells within the grafted site-are recommended.
Non-resorbable membranes retain their shape and structure in the tissues, requiring a second surgical procedure for removal, with consequent additional patient discomfort, and a raise in the costs and duration of the therapy. Non-resorbable membranes include: (i) expanded polytetrafluoroethylene (e-PTFE, Gore-Tex®); (ii) high-density polytetrafluoroethylene (d-PTFE) and (iii) titanium-reinforced expanded polytetrafluoroethylene (Ti-e-PTFE) membranes. The PTFE physico-chemical, thermal, and mechanical properties make it one of the most inert materials.The microstructure of e-PTFE consists of solid nodes interconnected by fine, highly oriented fibrils, providing a unique porous structure. The e-PTFE membranes, first used in 1984, have different structural features at both membrane sides.Effectiveness of e-PTFE membranes was investigated in numerous clinical studies, that confirmed their excellent biocompatibility, leading to a significant bone regeneration after 3- and 6-month healing period .However, drawbacks of e-PTFE membranes are (i) the need for a second surgical procedure and (ii) membrane stiffness that may result in soft tissue dehiscence (which is the cause of failure during the first 3 weeks after membrane implantation), allowing the exposure of the membrane to bacterial infection.
The d-PTFE membrane, developed in 1993, is a non-resorbable membrane, consisting of a high-density PTFE having submicron (0.2 μm) pores. The d-PTFE membranes do not require primary closure and preserve the full width of keratinized mucosa, producing an interesting advantage in respect to e-PTFE. Compared to e-PTFE membranes, the macroporosity of which enhances bacterial colonization upon exposure .the density of the d-PTFE membranes (i) prevents the infections as widely described by different authors .and (ii) makes membranes easy to be removed.
Titanium-reinforced barrier membranes were introduced (Cytoplast® TI-250 Titanium-Reinforced) by Jovanovic and Nevins . who reported the superior regenerative ability of these membranes in respect to the conventional e-PTFE ones. The titanium reinforcement provides mechanical support to the overlying soft tissue preventing its collapse into the defect. In addition, during the surgical procedure, titanium struts permit the surgeon to easily place the membrane under flaps with minimal dissection and flap reflection Native collagen membranes have rapid biodegradation by the enzymatic activity of macrophages and polymorphonuclear leucocytes occurs when using them. these membranes are well documented and have excellent results . they have good tissue integration and vascularization from periosteal side.there is a debate about what is more important biocompatibility or resorption time . The most important commercial collagen membrane is Bio-Gide®, which is based on Xenogenic collagen Type I form porcine skin and is characterized by a bilayered structure with a dense and a porous layer. The dense layer has a smooth surface able to avoid epithelial cell infiltration into bone defects, while the porous layer allows tissue integration.
- Conditions
- Missing Maxillary Anterior Teeth
- Being tested
- guided bone regenerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided bone regenerationsProcedure or surgery
intra oral procedures.
- Flap will be done.
- In the study group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks.
- In the control group: : bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral and packed at the defected area then covered by a titanium reinforced polytetraflouroethelene membrane which will be stabilized by tacks.
- The site will then be copiously irrigated with saline in preparation for closure.
- The flap will then be closed using interrupted 4/0 resorbable sutures.
| Study group | Role | What they receive |
|---|---|---|
| guided bone regeneration using ptfe | Active comparator | Augmented anterior maxillary bone ridge using ptfe with 1:1 autogenous bone and xenograft mixture
* Patients of both groups will be subjected to CBCT (diagnostic for upper arch).
* Intra operative procedures (for both groups) followed by CBCT will be taken for every patient.
* Local anesthesia will be given to the patient.
* Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
intervention:
* Flap will be done.
* In the group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a ptfe membrane which will be stabilized by tacks. Receives: Procedure: guided bone regenerations |
| collagen membrane | Experimental | * Local anesthesia will be given to the patient. intervention:
* Flap will be done.
* In the group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks. Receives: Procedure: guided bone regenerations |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of bone gained
using cbct 6 months after
Measured: 6 months
Secondary outcomes (1)
Bone area percentage
Histo-morphometric analysis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start26 Feb 2019 (estimated)
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Missing Maxillary Anterior TeethStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bassam ahmed abd elhameed alkholi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839615
- Sponsor's protocol ID
- GBR using ptfe vs collagen
- Status last verified
- Feb 2019
- First submitted
- 11 Dec 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tallgren A. The continuing reduction of the residual alveolar ridges in complete denture wearers: a mixed-longitudinal study covering 25 years. 1972. J Prosthet Dent. 2003 May;89(5):427-35. doi: 10.1016/s0022-3913(03)00158-6. No abstract available.
PubMed 12806317Pinho MN, Roriz VL, Novaes AB Jr, Taba M Jr, Grisi MF, de Souza SL, Palioto DB. Titanium membranes in prevention of alveolar collapse after tooth extraction. Implant Dent. 2006 Mar;15(1):53-61. doi: 10.1097/01.id.0000202596.18254.e1.
PubMed 16569962Kerr EN, Mealey BL, Noujeim ME, Lasho DJ, Nummikoski PV, Mellonig JT. The effect of ultrasound on bone dimensional changes following extraction: a pilot study. J Periodontol. 2008 Feb;79(2):283-90. doi: 10.1902/jop.2008.070289.
PubMed 18251642Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:260-71.
PubMed 19885449Lekovic V, Kenney EB, Weinlaender M, Han T, Klokkevold P, Nedic M, Orsini M. A bone regenerative approach to alveolar ridge maintenance following tooth extraction. Report of 10 cases. J Periodontol. 1997 Jun;68(6):563-70. doi: 10.1902/jop.1997.68.6.563.
PubMed 9203100Lekovic V, Camargo PM, Klokkevold PR, Weinlaender M, Kenney EB, Dimitrijevic B, Nedic M. Preservation of alveolar bone in extraction sockets using bioabsorbable membranes. J Periodontol. 1998 Sep;69(9):1044-9. doi: 10.1902/jop.1998.69.9.1044.
PubMed 9776033Iasella JM, Greenwell H, Miller RL, Hill M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol. 2003 Jul;74(7):990-9. doi: 10.1902/jop.2003.74.7.990.
PubMed 12931761Barone A, Aldini NN, Fini M, Giardino R, Calvo Guirado JL, Covani U. Xenograft versus extraction alone for ridge preservation after tooth removal: a clinical and histomorphometric study. J Periodontol. 2008 Aug;79(8):1370-7. doi: 10.1902/jop.2008.070628.
PubMed 18672985Camargo PM, Lekovic V, Weinlaender M, Klokkevold PR, Kenney EB, Dimitrijevic B, Nedic M, Jancovic S, Orsini M. Influence of bioactive glass on changes in alveolar process dimensions after exodontia. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Nov;90(5):581-6. doi: 10.1067/moe.2000.110035.
PubMed 11077380Fiorellini JP, Howell TH, Cochran D, Malmquist J, Lilly LC, Spagnoli D, Toljanic J, Jones A, Nevins M. Randomized study evaluating recombinant human bone morphogenetic protein-2 for extraction socket augmentation. J Periodontol. 2005 Apr;76(4):605-13. doi: 10.1902/jop.2005.76.4.605.
PubMed 15857102Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
PubMed 12956475Pietrokovski J, Massler M. Alveolar ridge resorption following tooth extraction. J Prosthet Dent. 1967 Jan;17(1):21-7. doi: 10.1016/0022-3913(67)90046-7. No abstract available.
PubMed 5224784Jahangiri L, Devlin H, Ting K, Nishimura I. Current perspectives in residual ridge remodeling and its clinical implications: a review. J Prosthet Dent. 1998 Aug;80(2):224-37. doi: 10.1016/s0022-3913(98)70116-7.
PubMed 9710828Pjetursson BE, Thoma D, Jung R, Zwahlen M, Zembic A. A systematic review of the survival and complication rates of implant-supported fixed dental prostheses (FDPs) after a mean observation period of at least 5 years. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:22-38. doi: 10.1111/j.1600-0501.2012.02546.x.
PubMed 23062125Aghaloo TL, Moy PK. Which hard tissue augmentation techniques are the most successful in furnishing bony support for implant placement? Int J Oral Maxillofac Implants. 2007;22 Suppl:49-70.
PubMed 18437791
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Poly Tetra Fluro Ethylene Membrane Versus Native Collagen Membrane With Guided Bone Regeneration In Atrophic Anterior Maxilla Using (1:1) Of Autogenous Bone And Xenograft Mixture (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03839615
- Acronym / sponsor ID
- GBR using ptfe vs collagen
- Conditions
- Missing Maxillary Anterior Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 26 Feb 2019 (estimated)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 15 Feb 2019 (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.
evaluation of amount of bone gained in the anterior maxilla using collagen membranes vs ptfe membrane while using a 1:1 mix of xenograft and autogenous bone
Detailed description
The alveolar bone is formed during tooth eruption, and consists of maxillary and mandibular components that shape and support the alveolar sockets. When teeth are lost, alveolar atrophy occurs, ultimately resulting in a short and narrow alveolar ridge . Such changes in the alveolar bone have a significant effect on prosthetic restoration planning, and are particularly important for areas with esthetic requirements, such as the maxillary incisors. Since preservation of the alveolar bone after extraction makes implant placement and prosthetic restoration easier in the edentulous jaw, alveolar ridge preservation and reconstruction methods using various bone graft materials together with resorbable and non-resorbable membranes have been introduced in order to minimize the loss of alveolar bone after extraction.
Investigations of changes in the alveolar bone after extraction have frequently been performed through clinical measurements and radiographic analysis. In particular, after the extraction of a tooth with fracture or severe periodontitis, the alveolar bone shows severe horizontal and vertical atrophy. The reduction in the width of the alveolar ridge is more notable in the horizontal direction than in the vertical direction, and the buccal wall of the alveolar bone has been reported to undergo greater vertical atrophy than the lingual wall. Changes in the width of the alveolar ridge after extraction occur in a relatively short time, decreasing most rapidly within the first six months after extraction, followed by continual, slow bone resorption over the course of the rest of the patient's life .
When a tooth has been lost, the extent of alveolar bone resorption is affected by a range of factors, including the number of extracted teeth and bone walls, the bone density, the extent of alveolar bone loss, infection, and the presence or absence of adjacent teeth.
Dental implant has become a predictable treatment option, with excellent long-term results. However, the success of implant therapy depends on the amount of bone volume at the insertion site.Unfavorable local conditions may provide insufficient bone volume that negatively affects the prognosis of dental implants. Cawood and Howell in 1988 ranked the atrophy degree of edentulous jaws in six classes. Particularly, atrophies within class IV, also known as "knife-edge" ridges, present a serious horizontal defect, making challenging the placement of regular implants.
Many techniques have been developed to regenerate atrophic alveolar jaws for the placement of dental implants, performed either in combination with graft procedures or in second stage surgery after a period of healing. For many years, bone blocks represented the gold standard to reconstruct the alveolar ridge bone defects. This technique requires to harvest a wide amount of bone to rebuild the atrophic crest.(20). For this reason, bone blocks were often harvested from extra-oral sites with an higher morbidity. Moreover some problems can occur when a combined defects (horizontal and vertical) need to be treated. Guided bone regeneration (GBR) has been proposed as a possible alternative for patients with severe horizontal bone atrophy, to overcome the drawback of bone blocks techniques. To protect and prevent the invasion of the clot by nonosteogenic cells, maintaining an adequate biological space for the regeneration of bone tissue, the use of both non-resorbable or resorbable membranes, in combination with autologous or heterologous particulate bone have been proposed. Particulated autogenous bone can be mixed with bone substitutes to add more osteogenic factors.
Guided bone regeneration or GBR, and guided tissue regeneration or GTR are dental surgical procedures that use barrier membranes to direct the growth of new bone and gingival tissue at sites with insufficient volumes or dimensions of bone or gingiva for proper function, esthetics or prosthetic restoration.
GBR is similar to guided tissue regeneration (GTR) but is focused on development of hard tissues in addition to the soft tissues of the periodontal attachment. At present, guided bone regeneration is predominantly applied in the oral cavity to support new hard tissue growth on an alveolar ridge to allow stable placement of dental implants.
The first application of barrier membranes in the mouth occurred in 1982. in the context of regeneration of periodontal tissues via GTR, as an alternative to resective surgical procedures to reduce pocket depths.Barrier membrane is utilized in GBR technique to cover the bone defect and create a secluded space, which prevents the connective tissue from growing into the space and facilitates the growth priority of bone tissue.
Several surgical techniques via GBR have been proposed regarding the tri-dimensional bone reconstruction of the severely resorbed maxilla, using different types of bone substitutes that have regenerative, osseoinductive or osseoconductive properties which is then packed into the bony defect and covered by resorbable membranes. In cases where augmentation materials used are autografts or allografts the bone density is quite low and resorption of the grafted site in these cases can reach up to 30% of original volume. For higher predictability, nonresorbable titanium-reinforced d-polytetrafluoroethylene (d-PTFE) membranes-as a barrier against the migration of epithelial cells within the grafted site-are recommended.
Non-resorbable membranes retain their shape and structure in the tissues, requiring a second surgical procedure for removal, with consequent additional patient discomfort, and a raise in the costs and duration of the therapy. Non-resorbable membranes include: (i) expanded polytetrafluoroethylene (e-PTFE, Gore-Tex®); (ii) high-density polytetrafluoroethylene (d-PTFE) and (iii) titanium-reinforced expanded polytetrafluoroethylene (Ti-e-PTFE) membranes. The PTFE physico-chemical, thermal, and mechanical properties make it one of the most inert materials.The microstructure of e-PTFE consists of solid nodes interconnected by fine, highly oriented fibrils, providing a unique porous structure. The e-PTFE membranes, first used in 1984, have different structural features at both membrane sides.Effectiveness of e-PTFE membranes was investigated in numerous clinical studies, that confirmed their excellent biocompatibility, leading to a significant bone regeneration after 3- and 6-month healing period .However, drawbacks of e-PTFE membranes are (i) the need for a second surgical procedure and (ii) membrane stiffness that may result in soft tissue dehiscence (which is the cause of failure during the first 3 weeks after membrane implantation), allowing the exposure of the membrane to bacterial infection.
The d-PTFE membrane, developed in 1993, is a non-resorbable membrane, consisting of a high-density PTFE having submicron (0.2 μm) pores. The d-PTFE membranes do not require primary closure and preserve the full width of keratinized mucosa, producing an interesting advantage in respect to e-PTFE. Compared to e-PTFE membranes, the macroporosity of which enhances bacterial colonization upon exposure .the density of the d-PTFE membranes (i) prevents the infections as widely described by different authors .and (ii) makes membranes easy to be removed.
Titanium-reinforced barrier membranes were introduced (Cytoplast® TI-250 Titanium-Reinforced) by Jovanovic and Nevins . who reported the superior regenerative ability of these membranes in respect to the conventional e-PTFE ones. The titanium reinforcement provides mechanical support to the overlying soft tissue preventing its collapse into the defect. In addition, during the surgical procedure, titanium struts permit the surgeon to easily place the membrane under flaps with minimal dissection and flap reflection Native collagen membranes have rapid biodegradation by the enzymatic activity of macrophages and polymorphonuclear leucocytes occurs when using them. these membranes are well documented and have excellent results . they have good tissue integration and vascularization from periosteal side.there is a debate about what is more important biocompatibility or resorption time . The most important commercial collagen membrane is Bio-Gide®, which is based on Xenogenic collagen Type I form porcine skin and is characterized by a bilayered structure with a dense and a porous layer. The dense layer has a smooth surface able to avoid epithelial cell infiltration into bone defects, while the porous layer allows tissue integration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| guided bone regeneration using ptfe | Active comparator | Procedure: guided bone regenerationsAugmented anterior maxillary bone ridge using ptfe with 1:1 autogenous bone and xenograft mixture * Patients of both groups will be subjected to CBCT (diagnostic for upper arch). * Intra operative procedures (for both groups) followed by CBCT will be taken for every patient. * Local anesthesia will be given to the patient. * Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. intervention: * Flap will be done. * In the group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a ptfe membrane which will be stabilized by tacks. |
| collagen membrane | Experimental | Procedure: guided bone regenerations* Local anesthesia will be given to the patient. intervention: * Flap will be done. * In the group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- • Heavy smokers more than 20 cigarettes per day.(32)
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 |
|---|---|---|
| guided bone regenerationsintra oral procedures. * Flap will be done. * In the study group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks. * In the control group: : bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral and packed at the defected area then covered by a titanium reinforced polytetraflouroethelene membrane which will be stabilized by tacks. * The site will then be copiously irrigated with saline in preparation for closure. * The flap will then be closed using interrupted 4/0 resorbable sutures. | Procedure or surgery | collagen membrane, guided bone regeneration using ptfe |
Primary outcome
amount of bone gained
Time frame: 6 months
using cbct 6 months after
1 secondary outcome
Bone area percentage
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Background: PubMed 12806317Tallgren A. The continuing reduction of the residual alveolar ridges in complete denture wearers: a mixed-longitudinal study covering 25 years. 1972. J Prosthet Dent. 2003 May;89(5):427-35. doi: 10.1016/s0022-3913(03)00158-6. No abstract available.
- Background: PubMed 16569962Pinho MN, Roriz VL, Novaes AB Jr, Taba M Jr, Grisi MF, de Souza SL, Palioto DB. Titanium membranes in prevention of alveolar collapse after tooth extraction. Implant Dent. 2006 Mar;15(1):53-61. doi: 10.1097/01.id.0000202596.18254.e1.
- Background: PubMed 18251642Kerr EN, Mealey BL, Noujeim ME, Lasho DJ, Nummikoski PV, Mellonig JT. The effect of ultrasound on bone dimensional changes following extraction: a pilot study. J Periodontol. 2008 Feb;79(2):283-90. doi: 10.1902/jop.2008.070289.
- Background: PubMed 19885449Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:260-71.
- Background: PubMed 9203100Lekovic V, Kenney EB, Weinlaender M, Han T, Klokkevold P, Nedic M, Orsini M. A bone regenerative approach to alveolar ridge maintenance following tooth extraction. Report of 10 cases. J Periodontol. 1997 Jun;68(6):563-70. doi: 10.1902/jop.1997.68.6.563.
- Background: PubMed 9776033Lekovic V, Camargo PM, Klokkevold PR, Weinlaender M, Kenney EB, Dimitrijevic B, Nedic M. Preservation of alveolar bone in extraction sockets using bioabsorbable membranes. J Periodontol. 1998 Sep;69(9):1044-9. doi: 10.1902/jop.1998.69.9.1044.
- Background: PubMed 12931761Iasella JM, Greenwell H, Miller RL, Hill M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol. 2003 Jul;74(7):990-9. doi: 10.1902/jop.2003.74.7.990.
- Background: PubMed 18672985Barone A, Aldini NN, Fini M, Giardino R, Calvo Guirado JL, Covani U. Xenograft versus extraction alone for ridge preservation after tooth removal: a clinical and histomorphometric study. J Periodontol. 2008 Aug;79(8):1370-7. doi: 10.1902/jop.2008.070628.
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- 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. This study is not recruiting at the moment.
mohamed atef, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guided bone regenerations in people with Missing Maxillary Anterior Teeth, run by Cairo University at 1 site in Egypt.
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 0 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact bassam ahmed, priciple investigator (01025266868, dr.besoahmed@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of bone gained (time frame: 6 months). 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 NCT03839615, which also lists 28 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 15 Feb 2019.