Socket PreservationNCT03573193
Radiographic Changes Following Socket Preservation in Molars Using Bovine Bone Versus Using Beta Tri ca.ph
A study testing ridge preservation in people with Socket Preservation, run by Cairo University.
Trial summary
Inadequate ridge width to allow implant placement, it noted that when extraction takes place and ridge preservation is not utilized the site of extraction could lose 40% to 60% of bone height and width within 2 to 3 years and subsequent loss of 0.25% to 0.5% annually. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Socket Preservation
- What is being tested?
- ridge preservation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Dec 2018
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Good oral hygiene.
- Age from 25-60 years
- Both sexes
- Sufficient bone volume
- Presence of non-restorable mandibular molars.
Who cannot join
- Extreme bone atrophy.
- Patients who have systemic disorders that might interfere with bone metabolism.
- Pregnant patients.
- Bad oral hygiene.
- Patients with bone diseases.
- Patient with limited mouth opening
Trial locations and contacts
No sites are listed yet.
mohammed A abd rassoul, p.h.d contact
About this study
Official title: Radiographic Bone Changes Following Socket Preservation in Mandibular Molars Using Deproteinized Bovine Bone Mineral Versus Using Beta Tri Calcium Phosphate
Inadequate ridge width to allow implant placement, it noted that when extraction takes place and ridge preservation is not utilized the site of extraction could lose 40% to 60% of bone height and width within 2 to 3 years and subsequent loss of 0.25% to 0.5% annually. it reported as much as 4 mm loss of ridge width in extraction alone sites within 6 months. Using an atraumatic tooth extraction technique preserves osseous walls thereby improving the chances of osseous graft success.
The goal of ridge preservation is minimizing bone loss to preserve the maximum final, healed ridge dimensions.
Socket preservation is done using a hard tissue graft like xenograft bone or synthetic bone substitutes and prevent hazard of surgical intervention which needed during implant loading due to bone resorption.
Read the detailed description
Good assessment whether a particular graft is more beneficial than others which can be improve the extraction site healing.
Good assessment if grafting has any beneficial or detrimental effects on post-operative sequelae post extraction.
Extraction is indicated when a tooth cannot be restored or maintained in suitable conditions for long-term health, function, and/or esthetics. Loss of a tooth has a direct effect on life quality by impairing the ability to masticate, speak, and, in some instances, socialize, after tooth extraction an average alveolar bone loss of 1.5-2 mm (vertical) and 40%-50% (horizontal) occurs within 6 months, alveolar dimensional changes occur during the first 3 months. If no treatment to restore the dentition is provided, then continued bone loss occurs and up to 40%-60% of ridge volume is lost in first 3 years . And the absence of a tooth in its alveolus enhances a cascade of biological events that typically result in significant local anatomic changes..
Studies have demonstrated that loss of alveolar ridge Post extraction is an irreversible process result in both horizontal and vertical reduction. Atrophy of alveolar ridge may have a significant effect on tooth replacement therapy, especially when implant restorations are planned.
Therefore, alveolar ridge preservation has become a key component of contemporary clinical dentistry.
Past therapy attempts to prevent resorption of alveolar ridge were performed by root retention, with the primary goal of maximizing the stability of removable prostheses. In spite of that, root retention is not always practical because of fracture, caries, and/or strategic reasons.
Alveolar ridge preservation via "socket grafting" started in the mid-1980s as a therapeutic alternative to root submergence. Its use was rationalized on the opinion that "filling" the space left by the extracted tooth with a biomaterial would simulate a "root retention effect" conducive to bone preservation, which would subsequently facilitate placement of implant by reducing the need of additional grafting procedures. This approach gained popularity over the years because of its conceptual attractiveness and simple technical procedures.
Over the past twenty years, multiple studies evaluating the efficacy of different socket-filling access have been conducted. In these studies, many of biomaterials have been employed, including autologous bone, bone substitutes (allografts, xenografts, and alloplasts), bioactive agents, and autologous blood-derived products.
Use of a grafting material with or without a membrane (alveolar ridge preservation) give additional support for stabilization of blood clot and space maintenance, bone loss is reduced from 69% to 25% or less. Objective of alveolar ridge preservation reduces bone loss, reduce the need for additional bone, and provide soft tissue support. And sinus augmentation procedures . finally providing for easier implant placement and a higher potential of achieving an esthetic restorative outcome.
Ridge preservation procedures are indicated when buccal plate thickness less than 1.5-2mm (most anterior and esthetic zones), damage or loss of one or more socket walls, maintaining bone volume is crucial to minimize the risk to adjacent anatomical structures, patients where many teeth are being extracted and preservation of bone is important for further restoration, and patients with high esthetic demands such as a high lip line and thin biotype, which are more prone to tissue loss.
Xenogenic Bone Grafts (Xenografts): Xenografts are derived from other species; Grafts are harvested from animals, mainly cows. That is why this is processed to make it totally biocompatible and sterile.
Advantages of xenografts:
- Only one simple procedure is needed as the bone is not being harvested from the patient in dangerous surgical procedures and it will encourage Natural bone growth.
Disadvantage of xenografts:
Is the minimal risk of bovine sponge form encephalopathy due to the fact that all organic components of the bone are extracted? The most widely used xenograft bone is deproteinized bovine bone mineral. Xenograft bone has similar properties to human cancellous bone, in its crystalline content and its macrostructure; it also has similar physical properties to the human bone This is a purely mineral graft and is osteoconductive but also some resorption will happen, so its use also has limitation. When used in a particulate form it is mixed with the patient's blood and packed into the defect.
They are materials with their organic components totally removed, With their removal, concern about immunological reactions becomes nonexistent, The remaining inorganic structure provides a natural architectural matrix as well as an excellent source of calcium The inorganic material also maintains the physical dimension of the augmentation during the remodeling phases.
choice of comparators: Alloplasts are synthetic bone substitutes. They are made of inorganic biocompatible materials including synthetic hydroxyapatite, tricalcium phosphate, bioactive glass, and calcium carbonate. Whether synthetic hydroxyapatite is resorbable or nonresorbable depends on the temperature at which it is prepared.
High-temperature preparation of hydroxyapatite results in a nonresorbable, dense material, nonporous, which is used as filler. Tricalcium phosphate acts as filler and is partially resorbable. Calcium carbonate, which is derived from coral, is biocompatible and resorbable so that it acts as filler, which eventually may be replaced by new bone. Bioactive glass is a silicone-based, osteoconductive material that bonds to bone through the formation of carbonated hydroxyapatite.
The advantage of alloplasts is that they have no potential for disease transmission.
Among the most promising is the tricalcium phosphate , an alloplastic ceramic material studied and used extensively in the past decade. It is considered to be bioactive (by means of inducing specific biologic reactions) and (not stimulating inflammatory or foreign-body giant cell activity) biocompatible.
This is mainly because tricalcium phosphate is composed of Ca and P ions, which are the most commonly found elements in bone. However, tricalcium phosphate cements have a slower resorption rate than bone and are usually too dense to allow bone tissue to grow into the defect in a limited period of time.
By adding a faster resorbing material, pores may be created, ensuring new bone tissue growing into the defect.
Tricalcium phosphate as a bone graft substitute has been evaluated at length in previous studies. It binds to bone by means of mechanical anchorage with no formation of intermediate apatite layer. Bioresorption of tricalcium phosphate granules occurs due to chemical dissolution in biological fluids and cellular degradation.
Solubilization is induced by mesenchymal cells, which are also actively involved in the degradation process.
the capability of osteoplastic cells, fibroblasts, and osteoclasts to degrade TCP ceramic material. Monocyte/macrophage participation is well documented in vivo as well as in vitro.
It seems that the more soluble a CaP ceramic, the more rapidly it is resorbed by osteoclasts. However, the increased number of released calcium ions may, on one hand, inhibit osteoclasts' activity, while on the other hand, it provides a good environment for osteogenesis. Therefore, it seems that Tricalcium phosphate resorption is performed at a rather unpredictable rate that does not always correspond to the new bone formation rate. This behavior is evident in the conflicting results of many studies on the bioresorption of TCP.
The βeta- phase isomer of Tricalcium phosphate (β -Tricalcium phosphate ), however, is characterized by homogenous microporosity, physiologic pH, increased solubility, and a more predictable resorption rate that look alike the new bone remodeling rate. Composition or impurities Variations may affect solubility, whereas the pure phase seems to be resorbed in 5 to 6 months.
It should be noted that a faster resorbable material might allow soft-tissue cells to prematurely intrude into the defect, while slowly resorbable or nonresorbable materials that remain for a long time may inhibit new bone deposition.
- Conditions
- Socket Preservation
- Being tested
- ridge preservation
- Keywords
- xenograft bone, synthetic bone substitutes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ridge preservationOther
Intra operative procedures (for both groups) ridge preservation
- 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.
- A crestal incision was made, and a mucoperiosteal flap was elevated. Implant osteotomies were prepared according to the recommendations and desired dimensions of implants.
- In study group: tooth extraction with ridge preservation using deproteinized bovine bone mineral Bio-Oss
- In the comparators group: tooth extraction with ridge preservation using an alloplastic ceramic material beta tricalcium phosphate (TCP).
| Study group | Role | What they receive |
|---|---|---|
| study group: | Active comparator | ridge preservation alveolar ridge socket preserved using alloplastic material beta tri calcium phosphate type Receives: Other: ridge preservation |
| control group | Other | ridge preservation (alveolar ridge socket preserved using xenograft material Bio-oss type Receives: Other: ridge preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevent post extraction ridge volume loss and decrease bone resorption detected by CBCT to prepare for success implant loading
socket preservation is minimizing bone loss to preserve the maximum final, healed ridge dimensions
Measured: base lline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study startJul 2018 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Socket PreservationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial. • Unicenter, single blinded, with equal randomization, active controlled, parallel group study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wahid yehia al azizy al hussiney, Cairo University
- Investigators
- AMR A al azim, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573193
- Sponsor's protocol ID
- socket preservation
- Status last verified
- Jun 2018
- First submitted
- 13 Jun 2018
- Last updated
- 29 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gerritsen AE, Allen PF, Witter DJ, Bronkhorst EM, Creugers NH. Tooth loss and oral health-related quality of life: a systematic review and meta-analysis. Health Qual Life Outcomes. 2010 Nov 5;8:126. doi: 10.1186/1477-7525-8-126.
PubMed 21050499Schropp 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 12956475Van der Weijden F, Dell'Acqua F, Slot DE. Alveolar bone dimensional changes of post-extraction sockets in humans: a systematic review. J Clin Periodontol. 2009 Dec;36(12):1048-58. doi: 10.1111/j.1600-051X.2009.01482.x.
PubMed 19929956Seibert JS, Salama H. Alveolar ridge preservation and reconstruction. Periodontol 2000. 1996 Jun;11:69-84. doi: 10.1111/j.1600-0757.1996.tb00185.x. No abstract available.
PubMed 9567959Osburn RC. Preservation of the alveolar ridge: a simplified technique for retaining teeth beneath removable appliances. J Indiana State Dent Assoc. 1974 Jan-Feb;53(1):8-11. No abstract available.
PubMed 4523604Artzi Z, Nemcovsky CE. The application of deproteinized bovine bone mineral for ridge preservation prior to implantation. Clinical and histological observations in a case report. J Periodontol. 1998 Sep;69(9):1062-7. doi: 10.1902/jop.1998.69.9.1062.
PubMed 9776036Christensen GJ. Ridge preservation: why not? J Am Dent Assoc. 1996 May;127(5):669-70. doi: 10.14219/jada.archive.1996.0279.
PubMed 8642146Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:260-71.
PubMed 19885449Tallgren A. The continuing reduction of the residual alveolar ridges in complete denture wearers: a mixed-longitudinal study covering 25 years. J Prosthet Dent. 1972 Feb;27(2):120-32. doi: 10.1016/0022-3913(72)90188-6. No abstract available.
PubMed 4500507Hammerle CH, Araujo MG, Simion M; Osteology Consensus Group 2011. Evidence-based knowledge on the biology and treatment of extraction sockets. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:80-2. doi: 10.1111/j.1600-0501.2011.02370.x.
PubMed 22211307De Buitrago JG, Avila-Ortiz G, Elangovan S. Quality assessment of systematic reviews on alveolar ridge preservation. J Am Dent Assoc. 2013 Dec;144(12):1349-57. doi: 10.14219/jada.archive.2013.0070.
PubMed 24282264Omran M, Min S, Abdelhamid A, Liu Y, Zadeh HH. Alveolar ridge dimensional changes following ridge preservation procedure: part-2 - CBCT 3D analysis in non-human primate model. Clin Oral Implants Res. 2016 Jul;27(7):859-66. doi: 10.1111/clr.12701. Epub 2015 Oct 25.
PubMed 26498407Barone A, Orlando B, Cingano L, Marconcini S, Derchi G, Covani U. A randomized clinical trial to evaluate and compare implants placed in augmented versus non-augmented extraction sockets: 3-year results. J Periodontol. 2012 Jul;83(7):836-46. doi: 10.1902/jop.2011.110205. Epub 2011 Dec 5.
PubMed 22141358Rasperini G, Canullo L, Dellavia C, Pellegrini G, Simion M. Socket grafting in the posterior maxilla reduces the need for sinus augmentation. Int J Periodontics Restorative Dent. 2010 Jun;30(3):265-73.
PubMed 20386783Darby I, Chen S, De Poi R. Ridge preservation: what is it and when should it be considered. Aust Dent J. 2008 Mar;53(1):11-21. doi: 10.1111/j.1834-7819.2007.00008.x.
PubMed 18304236
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Bone Changes Following Socket Preservation in Mandibular Molars Using Deproteinized Bovine Bone Mineral Versus Using Beta Tri Calcium Phosphate
- ClinicalTrials.gov ID
- NCT03573193
- Acronym / sponsor ID
- socket preservation
- Conditions
- Socket Preservation
- Keywords
- xenograft bone, synthetic bone substitutes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Jun 2018 (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.
Inadequate ridge width to allow implant placement, it noted that when extraction takes place and ridge preservation is not utilized the site of extraction could lose 40% to 60% of bone height and width within 2 to 3 years and subsequent loss of 0.25% to 0.5% annually. it reported as much as 4 mm loss of ridge width in extraction alone sites within 6 months. Using an atraumatic tooth extraction technique preserves osseous walls thereby improving the chances of osseous graft success.
The goal of ridge preservation is minimizing bone loss to preserve the maximum final, healed ridge dimensions.
Socket preservation is done using a hard tissue graft like xenograft bone or synthetic bone substitutes and prevent hazard of surgical intervention which needed during implant loading due to bone resorption.
Detailed description
Good assessment whether a particular graft is more beneficial than others which can be improve the extraction site healing.
Good assessment if grafting has any beneficial or detrimental effects on post-operative sequelae post extraction.
Extraction is indicated when a tooth cannot be restored or maintained in suitable conditions for long-term health, function, and/or esthetics. Loss of a tooth has a direct effect on life quality by impairing the ability to masticate, speak, and, in some instances, socialize, after tooth extraction an average alveolar bone loss of 1.5-2 mm (vertical) and 40%-50% (horizontal) occurs within 6 months, alveolar dimensional changes occur during the first 3 months. If no treatment to restore the dentition is provided, then continued bone loss occurs and up to 40%-60% of ridge volume is lost in first 3 years . And the absence of a tooth in its alveolus enhances a cascade of biological events that typically result in significant local anatomic changes..
Studies have demonstrated that loss of alveolar ridge Post extraction is an irreversible process result in both horizontal and vertical reduction. Atrophy of alveolar ridge may have a significant effect on tooth replacement therapy, especially when implant restorations are planned.
Therefore, alveolar ridge preservation has become a key component of contemporary clinical dentistry.
Past therapy attempts to prevent resorption of alveolar ridge were performed by root retention, with the primary goal of maximizing the stability of removable prostheses. In spite of that, root retention is not always practical because of fracture, caries, and/or strategic reasons.
Alveolar ridge preservation via "socket grafting" started in the mid-1980s as a therapeutic alternative to root submergence. Its use was rationalized on the opinion that "filling" the space left by the extracted tooth with a biomaterial would simulate a "root retention effect" conducive to bone preservation, which would subsequently facilitate placement of implant by reducing the need of additional grafting procedures. This approach gained popularity over the years because of its conceptual attractiveness and simple technical procedures.
Over the past twenty years, multiple studies evaluating the efficacy of different socket-filling access have been conducted. In these studies, many of biomaterials have been employed, including autologous bone, bone substitutes (allografts, xenografts, and alloplasts), bioactive agents, and autologous blood-derived products.
Use of a grafting material with or without a membrane (alveolar ridge preservation) give additional support for stabilization of blood clot and space maintenance, bone loss is reduced from 69% to 25% or less. Objective of alveolar ridge preservation reduces bone loss, reduce the need for additional bone, and provide soft tissue support. And sinus augmentation procedures . finally providing for easier implant placement and a higher potential of achieving an esthetic restorative outcome.
Ridge preservation procedures are indicated when buccal plate thickness less than 1.5-2mm (most anterior and esthetic zones), damage or loss of one or more socket walls, maintaining bone volume is crucial to minimize the risk to adjacent anatomical structures, patients where many teeth are being extracted and preservation of bone is important for further restoration, and patients with high esthetic demands such as a high lip line and thin biotype, which are more prone to tissue loss.
Xenogenic Bone Grafts (Xenografts): Xenografts are derived from other species; Grafts are harvested from animals, mainly cows. That is why this is processed to make it totally biocompatible and sterile.
Advantages of xenografts:
- Only one simple procedure is needed as the bone is not being harvested from the patient in dangerous surgical procedures and it will encourage Natural bone growth.
Disadvantage of xenografts:
Is the minimal risk of bovine sponge form encephalopathy due to the fact that all organic components of the bone are extracted? The most widely used xenograft bone is deproteinized bovine bone mineral. Xenograft bone has similar properties to human cancellous bone, in its crystalline content and its macrostructure; it also has similar physical properties to the human bone This is a purely mineral graft and is osteoconductive but also some resorption will happen, so its use also has limitation. When used in a particulate form it is mixed with the patient's blood and packed into the defect.
They are materials with their organic components totally removed, With their removal, concern about immunological reactions becomes nonexistent, The remaining inorganic structure provides a natural architectural matrix as well as an excellent source of calcium The inorganic material also maintains the physical dimension of the augmentation during the remodeling phases.
choice of comparators: Alloplasts are synthetic bone substitutes. They are made of inorganic biocompatible materials including synthetic hydroxyapatite, tricalcium phosphate, bioactive glass, and calcium carbonate. Whether synthetic hydroxyapatite is resorbable or nonresorbable depends on the temperature at which it is prepared.
High-temperature preparation of hydroxyapatite results in a nonresorbable, dense material, nonporous, which is used as filler. Tricalcium phosphate acts as filler and is partially resorbable. Calcium carbonate, which is derived from coral, is biocompatible and resorbable so that it acts as filler, which eventually may be replaced by new bone. Bioactive glass is a silicone-based, osteoconductive material that bonds to bone through the formation of carbonated hydroxyapatite.
The advantage of alloplasts is that they have no potential for disease transmission.
Among the most promising is the tricalcium phosphate , an alloplastic ceramic material studied and used extensively in the past decade. It is considered to be bioactive (by means of inducing specific biologic reactions) and (not stimulating inflammatory or foreign-body giant cell activity) biocompatible.
This is mainly because tricalcium phosphate is composed of Ca and P ions, which are the most commonly found elements in bone. However, tricalcium phosphate cements have a slower resorption rate than bone and are usually too dense to allow bone tissue to grow into the defect in a limited period of time.
By adding a faster resorbing material, pores may be created, ensuring new bone tissue growing into the defect.
Tricalcium phosphate as a bone graft substitute has been evaluated at length in previous studies. It binds to bone by means of mechanical anchorage with no formation of intermediate apatite layer. Bioresorption of tricalcium phosphate granules occurs due to chemical dissolution in biological fluids and cellular degradation.
Solubilization is induced by mesenchymal cells, which are also actively involved in the degradation process.
the capability of osteoplastic cells, fibroblasts, and osteoclasts to degrade TCP ceramic material. Monocyte/macrophage participation is well documented in vivo as well as in vitro.
It seems that the more soluble a CaP ceramic, the more rapidly it is resorbed by osteoclasts. However, the increased number of released calcium ions may, on one hand, inhibit osteoclasts' activity, while on the other hand, it provides a good environment for osteogenesis. Therefore, it seems that Tricalcium phosphate resorption is performed at a rather unpredictable rate that does not always correspond to the new bone formation rate. This behavior is evident in the conflicting results of many studies on the bioresorption of TCP.
The βeta- phase isomer of Tricalcium phosphate (β -Tricalcium phosphate ), however, is characterized by homogenous microporosity, physiologic pH, increased solubility, and a more predictable resorption rate that look alike the new bone remodeling rate. Composition or impurities Variations may affect solubility, whereas the pure phase seems to be resorbed in 5 to 6 months.
It should be noted that a faster resorbable material might allow soft-tissue cells to prematurely intrude into the defect, while slowly resorbable or nonresorbable materials that remain for a long time may inhibit new bone deposition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized clinical trial. • Unicenter, single blinded, with equal randomization, active controlled, parallel group study
| Arm | Type | Receives |
|---|---|---|
| study group: | Active comparator | Other: ridge preservationridge preservation alveolar ridge socket preserved using alloplastic material beta tri calcium phosphate type |
| control group | Other | Other: ridge preservationridge preservation (alveolar ridge socket preserved using xenograft material Bio-oss type |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Good oral hygiene.
- Age from 25-60 years
- Both sexes
- Sufficient bone volume
- Presence of non-restorable mandibular molars.
Key exclusion criteria (6 listed)
- Extreme bone atrophy.
- Patients who have systemic disorders that might interfere with bone metabolism.
- Pregnant patients.
- Bad oral hygiene.
- Patients with bone diseases.
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 |
|---|---|---|
| ridge preservationIntra operative procedures (for both groups) ridge preservation * 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. * A crestal incision was made, and a mucoperiosteal flap was elevated. Implant osteotomies were prepared according to the recommendations and desired dimensions of implants. * In study group: tooth extraction with ridge preservation using deproteinized bovine bone mineral Bio-Oss * In the comparators group: tooth extraction with ridge preservation using an alloplastic ceramic material beta tricalcium phosphate (TCP). | Other | control group, study group: |
Primary outcome
Prevent post extraction ridge volume loss and decrease bone resorption detected by CBCT to prepare for success implant loading
Time frame: base lline
socket preservation is minimizing bone loss to preserve the maximum final, healed ridge dimensions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Results publication: PubMed 21050499Gerritsen AE, Allen PF, Witter DJ, Bronkhorst EM, Creugers NH. Tooth loss and oral health-related quality of life: a systematic review and meta-analysis. Health Qual Life Outcomes. 2010 Nov 5;8:126. doi: 10.1186/1477-7525-8-126.
- Results publication: PubMed 12956475Schropp 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.
- Results publication: PubMed 19929956Van der Weijden F, Dell'Acqua F, Slot DE. Alveolar bone dimensional changes of post-extraction sockets in humans: a systematic review. J Clin Periodontol. 2009 Dec;36(12):1048-58. doi: 10.1111/j.1600-051X.2009.01482.x.
- Results publication: PubMed 9567959Seibert JS, Salama H. Alveolar ridge preservation and reconstruction. Periodontol 2000. 1996 Jun;11:69-84. doi: 10.1111/j.1600-0757.1996.tb00185.x. No abstract available.
- Results publication: PubMed 4523604Osburn RC. Preservation of the alveolar ridge: a simplified technique for retaining teeth beneath removable appliances. J Indiana State Dent Assoc. 1974 Jan-Feb;53(1):8-11. No abstract available.
- Results publication: PubMed 9776036Artzi Z, Nemcovsky CE. The application of deproteinized bovine bone mineral for ridge preservation prior to implantation. Clinical and histological observations in a case report. J Periodontol. 1998 Sep;69(9):1062-7. doi: 10.1902/jop.1998.69.9.1062.
- Results publication: PubMed 8642146Christensen GJ. Ridge preservation: why not? J Am Dent Assoc. 1996 May;127(5):669-70. doi: 10.14219/jada.archive.1996.0279.
- Results publication: PubMed 19885449Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:260-71.
- Results publication: PubMed 4500507Tallgren A. The continuing reduction of the residual alveolar ridges in complete denture wearers: a mixed-longitudinal study covering 25 years. J Prosthet Dent. 1972 Feb;27(2):120-32. doi: 10.1016/0022-3913(72)90188-6. No abstract available.
- Results publication: PubMed 22211307Hammerle CH, Araujo MG, Simion M; Osteology Consensus Group 2011. Evidence-based knowledge on the biology and treatment of extraction sockets. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:80-2. doi: 10.1111/j.1600-0501.2011.02370.x.
- Results publication: PubMed 24282264De Buitrago JG, Avila-Ortiz G, Elangovan S. Quality assessment of systematic reviews on alveolar ridge preservation. J Am Dent Assoc. 2013 Dec;144(12):1349-57. doi: 10.14219/jada.archive.2013.0070.
- Results publication: PubMed 26498407Omran M, Min S, Abdelhamid A, Liu Y, Zadeh HH. Alveolar ridge dimensional changes following ridge preservation procedure: part-2 - CBCT 3D analysis in non-human primate model. Clin Oral Implants Res. 2016 Jul;27(7):859-66. doi: 10.1111/clr.12701. Epub 2015 Oct 25.
- Individual participant dataSharing planned: No
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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.
mohammed A abd rassoul, p.h.d contact
AMR A al azim, professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing ridge preservation in people with Socket Preservation, run by Cairo 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 5 inclusion and 6 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 29 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wahid Y al hussiney, B.D.S (01006881803 ext. 002, waw2sad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevent post extraction ridge volume loss and decrease bone resorption detected by CBCT to prepare for success implant loading (time frame: base lline). 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 NCT03573193, which also lists 33 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 29 Jun 2018.