Effect of Putty Form Bone Graft in Immediate Implant PlacmentNCT06783517
Evaluation of Hyaluronic Acid in Addition to Xenograft in Immediate Implant Placement Within Maxillary Esthetic Zone
A study testing cerabone and cerabone®plus in people with Effect of Putty Form Bone Graft in Immediate Implant Placment, run by Mansoura University at 1 site in Egypt.
Trial summary
Study design: The present study will be carried out on twenty patients selected from the department of Oral Medicine, Periodontology, Oral Diagnosis and Radiology, Faculty of Dentistry, Mansoura University for replacement of non restorable maxillary anterior and/or premolar teeth within esthetic zone by immediate… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Putty Form Bone Graft in Immediate Implant Placment
- What is being tested?
- cerabone and cerabone®plus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2023to 30 May 2025
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Patients who are medically free from any systemic diseases.
- Patients with good oral hygiene and regular maintenance.
- Age of patients will be >20 years.
- Presence of at least single non restorable maxillary anterior and/or premolar tooth due to caries, root resorption, endodontic failure, root fracture or tooth with open apex.
- No acute infection is present within both periodontal and/or peri-apical area within the tooth of concern and/or adjacent teeth.
- Patients with extraction socket type I.
- Free from history of clenching, tapping and bruxism.
- Patients prepared to co-operate and comply with the follow-up and maintenance program.
Who cannot join
- • Patients taking medications known to influence bone metabolism ( such as heparin, warfarin, corticosteroid).
- Smoking and alcoholic patients.
- History of radiation in the head and neck region.
- Insufficient interocclusal distance for implant placement and restoration.
- Patient with lack of stable posterior occlusion.
- Pregnant, lactating and post-menopausal female patients. Complete medical history, dental history will be taken to all of patients in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Hyaluronic Acid in Addition to Xenograft Material in Treatment Peri-implant Bony Defects in Immediate Implant Placement Within Maxillary Esthetic Zone
Study design:
The present study will be carried out on twenty patients selected from the department of Oral Medicine, Periodontology, Oral Diagnosis and Radiology, Faculty of Dentistry, Mansoura University for replacement of non restorable maxillary anterior and/or premolar teeth within esthetic zone by immediate implant divided into two groups. A written informed consent will be obtained from all patients before their participation in this study.
Read more
Evaluation of study:
All patients will be seen at regular time interval for evaluation at the visit of surgical intervention , follow up of clinical parameter will be recorded monthly then three , six months postoperative and six month after loading(with twelve month follow up study).
- Clinical evaluation: Implant stability evaluation Soft tissue evaluation
- Radiographic evaluation:
- Marginal bone loss(MBL).
Read the detailed description
Study design:
The present study will be carried out on two groups of patients.
A-Patients Sample:
Twenty patients selected from the department of Oral Medicine, Periodontology, Oral Diagnosis and Radiology, Faculty of Dentistry, Mansoura University for replacement of non restorable maxillary anterior and/or premolar teeth within esthetic zone by immediate implant. A written informed consent will be obtained from all patients before their participation in this study.
- Group (1): Comprised of ten patients with hopeless non-restorable maxillary anterior and/or premolar tooth within the esthetic zone will be extracted and replaced by an immediately placed dental implant in conjunction with Bovine bone mineral graft material( cerabone®,Botiss biomaterial) followed by healing abutment. ii. Group (2): Comprised of ten patients with hopeless non-restorable maxillary anterior and/or premolar tooth within the esthetic zone will be extracted and replaced by an immediately placed dental implant in conjunction with Bovine bone mineral with sodium hyaluronate graft material (cerabone®plus,Botiss biomaterial) followed by healing abutment.
Inclusion criteria:
- Patients who are medically free from any systemic diseases.
- Patients with good oral hygiene and regular maintenance.
- Age of patients will be >20 years.
- Presence of at least single non restorable maxillary anterior and/or premolar tooth due to caries, root resorption, endodontic failure, root fracture or tooth with open apex.
- No acute infection is present within both periodontal and/or peri-apical area within the tooth of concern and/or adjacent teeth.
- Patients with extraction socket type I.
- Free from history of clenching, tapping and bruxism.
- Patients prepared to co-operate and comply with the follow-up and maintenance program.
Exclusion criteria:
- Patients taking medications known to influence bone metabolism ( such as heparin, warfarin, corticosteroid).
- Smoking and alcoholic patients.
- History of radiation in the head and neck region.
- Insufficient interocclusal distance for implant placement and restoration.
- Patient with lack of stable posterior occlusion.
- Pregnant, lactating and post-menopausal female patients. Complete medical history, dental history will be taken to all of patients in the study.
Materials:
- Dental Implants: Conventional 2 pieces screw type dental implants. B. Bone substitute: Bovine bone graft material (cerabone®,Botiss biomaterial) and Bovine bone substitute with sodium hyaluronate graft material (cerabone®plus,Botiss biomaterial).
- Trephine bur: to create intentional bony defect in experimental rabbits. D. Ostell: to measure the primary and secondary stability of the implant.
Methods:
- Pre-operative measurements:
- Photographs: for all items under research. B. Preoperative Radiographs: CBCT will be taken for clinical patients before treatment.
- Antibiotic administration for both patients and rabbits before implant placement.
- Surgical Procedures:
- Clinical sample (patients) :
- Atraumatic removal of remaining root or tooth will be performed using periotome, appropriate forceps and elevators in an attempt to preserve the buccal plate of bone and soft tissue.
- Implant will be placed in fresh socket using implant motor with saline coolant after curettage and its size is determined according to pre-operative CBCT within both groups.
- Group (1): Bovine bone graft (cerabone®,Botiss biomaterial)will be added to the implant.
- Group (2): Bovine bone substitute with sodium hyaluronate graft (cerabone®plus,Botiss biomaterial) will be added to the implant.
- followed by healing abutment.
- Post-operative care: The patients will be instructed to consume soft food for eight weeks Patients will be maintained on amoxicillin twice a day for six days and Ibuprofen 400mg 2 to 4 times daily
- loading will begin at three to four months from surgical intervention. 3-Evaluation of study:
- Patients evaluation:
All patients will be seen at regular time interval for evaluation at the visit of surgical intervention , follow up of clinical parameter will be recorded monthly then three , six months postoperative and six month after loading(with twelve month follow up study).
- Clinical evaluation:
- Soft tissue evaluation: This will be done in both groups where, soft tissue evaluation will be done using probing depth(PD) and pink esthetic score (PES) around dental implant. ii. Implant stability evaluation: Using Osstell implant stability will be assessed in both groups soon after implant placement to assess primary implant stability then three , six and twelve months after surgery to assess secondary implant stability.
- Radiographic evaluation: Radiographic assessment will be held preoperative ,six and twelve months after implant placement for evaluation of:
- Marginal bone loss(MBL). Statistical Analysis: All data will be collected and statistically analyzed.
- Being tested
- cerabone, cerabone®plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceraboneProcedure or surgery
Atraumatic removal of remaining root or tooth will be performed Implant will be placed in fresh socket Bovine bone graft (cerabone®,Botiss biomaterial) will be added to the implant
cerabone®plusProcedure or surgery
Atraumatic removal of remaining root or tooth will be performed Implant will be placed in fresh socket Bovine bone substitute with sodium hyaluronate graft (cerabone®plus,Botiss biomaterial) will be added to the implant
| Study group | Role | What they receive |
|---|---|---|
| immediate dental implant with cerabone® | Experimental | Comprised of ten patients with hopeless non-restorable maxillary anterior and/or premolar tooth within the esthetic zone will be extracted and replaced by an immediately placed dental implant in conjunction with Bovine bone mineral graft material( cerabone®,Botiss biomaterial) followed by healing abutment. Receives: Procedure: cerabone |
| immediate dental implant with cerabone plus® | Active comparator | Comprised of ten patients with hopeless non-restorable maxillary anterior and/or premolar tooth within the esthetic zone will be extracted and replaced by an immediately placed dental implant in conjunction with Bovine bone mineral with sodium hyaluronate graft material (cerabone®plus,Botiss biomaterial) followed by healing abutment. Receives: Procedure: cerabone®plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic marginal bone change
Radiographic cone beam tomography (CBCT) assessment will be held preoperative ,at time implant placement, six and twelve months after implant placement
Measured: preoperative , at time implant placement, six and twelve months after implant placement
Implant stability evaluation
Using Osstell implant stability will be assessed in both groups soon after implant placement to assess primary implant stability then three , six months after surgery to assess secondary implant stability
Measured: at time of placement, three , six months after surgery to assess secondary implant stability
Secondary outcomes (1)
Soft tissue evaluation
This will be done in both groups where, soft tissue evaluation will be done using probing depth(PD) and pink esthetic score (PES) around dental implant
Measured: monthly then three , six months postoperative and six month after loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start30 Oct 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion30 May 2025 (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 Effect of Putty Form Bone Graft in Immediate Implant PlacmentStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia Mohamad Dakhil, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783517
- Sponsor's protocol ID
- A0104023OM
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Peric Kacarevic Z, Kavehei F, Houshmand A, Franke J, Smeets R, Rimashevskiy D, Wenisch S, Schnettler R, Jung O, Barbeck M. Purification processes of xenogeneic bone substitutes and their impact on tissue reactions and regeneration. Int J Artif Organs. 2018 Nov;41(11):789-800. doi: 10.1177/0391398818771530. Epub 2018 Apr 29.
PubMed 29707988Dos Santos PL, de Molon RS, Queiroz TP, Okamoto R, de Souza Faloni AP, Gulinelli JL, Luvizuto ER, Garcia IR Jr. Evaluation of bone substitutes for treatment of peri-implant bone defects: biomechanical, histological, and immunohistochemical analyses in the rabbit tibia. J Periodontal Implant Sci. 2016 Jun;46(3):176-96. doi: 10.5051/jpis.2016.46.3.176. Epub 2016 Jun 28.
PubMed 27382506Cohen DJ, Scott KM, Kulkarni AN, Wayne JS, Boyan BD, Schwartz Z. Acellular mineralized allogenic block bone graft does not remodel during the 10 weeks following concurrent implant placement in a rabbit femoral model. Clin Oral Implants Res. 2020 Jan;31(1):37-48. doi: 10.1111/clr.13544. Epub 2019 Oct 10.
PubMed 31545532Kyyak S, Blatt S, Wiesmann N, Smeets R, Kaemmerer PW. Hyaluronic Acid with Bone Substitutes Enhance Angiogenesis In Vivo. Materials (Basel). 2022 May 27;15(11):3839. doi: 10.3390/ma15113839.
PubMed 35683136Raines AL, Sunwoo M, Gertzman AA, Thacker K, Guldberg RE, Schwartz Z, Boyan BD. Hyaluronic acid stimulates neovascularization during the regeneration of bone marrow after ablation. J Biomed Mater Res A. 2011 Mar 1;96(3):575-83. doi: 10.1002/jbm.a.33012. Epub 2011 Jan 10.
PubMed 21254389Zhao N, Wang X, Qin L, Guo Z, Li D. Effect of molecular weight and concentration of hyaluronan on cell proliferation and osteogenic differentiation in vitro. Biochem Biophys Res Commun. 2015 Sep 25;465(3):569-74. doi: 10.1016/j.bbrc.2015.08.061. Epub 2015 Aug 15.
PubMed 26284973Pilloni A, Bernard GW. The effect of hyaluronan on mouse intramembranous osteogenesis in vitro. Cell Tissue Res. 1998 Nov;294(2):323-33. doi: 10.1007/s004410051182.
PubMed 9799448Guo J, Guo S, Wang Y, Yu Y. Adipose-derived stem cells and hyaluronic acid based gel compatibility, studied in vitro. Mol Med Rep. 2017 Oct;16(4):4095-4100. doi: 10.3892/mmr.2017.7055. Epub 2017 Jul 21.
PubMed 28731160Sasaki T, Watanabe C. Stimulation of osteoinduction in bone wound healing by high-molecular hyaluronic acid. Bone. 1995 Jan;16(1):9-15. doi: 10.1016/s8756-3282(94)00001-8.
PubMed 7742090Pirnazar P, Wolinsky L, Nachnani S, Haake S, Pilloni A, Bernard GW. Bacteriostatic effects of hyaluronic acid. J Periodontol. 1999 Apr;70(4):370-4. doi: 10.1902/jop.1999.70.4.370.
PubMed 10328647Kawano M, Ariyoshi W, Iwanaga K, Okinaga T, Habu M, Yoshioka I, Tominaga K, Nishihara T. Mechanism involved in enhancement of osteoblast differentiation by hyaluronic acid. Biochem Biophys Res Commun. 2011 Feb 25;405(4):575-80. doi: 10.1016/j.bbrc.2011.01.071. Epub 2011 Jan 23.
PubMed 21266161Grigolo B, Lisignoli G, Piacentini A, Fiorini M, Gobbi P, Mazzotti G, Duca M, Pavesio A, Facchini A. Evidence for redifferentiation of human chondrocytes grown on a hyaluronan-based biomaterial (HYAff 11): molecular, immunohistochemical and ultrastructural analysis. Biomaterials. 2002 Feb;23(4):1187-95. doi: 10.1016/s0142-9612(01)00236-8.
PubMed 11791922Knudson CB, Knudson W. Hyaluronan-binding proteins in development, tissue homeostasis, and disease. FASEB J. 1993 Oct;7(13):1233-41.
PubMed 7691670Bozic D, Catovic I, Badovinac A, Music L, Par M, Sculean A. Treatment of Intrabony Defects with a Combination of Hyaluronic Acid and Deproteinized Porcine Bone Mineral. Materials (Basel). 2021 Nov 11;14(22):6795. doi: 10.3390/ma14226795.
PubMed 34832196Kammerer PW, Scholz M, Baudisch M, Liese J, Wegner K, Frerich B, Lang H. Guided Bone Regeneration Using Collagen Scaffolds, Growth Factors, and Periodontal Ligament Stem Cells for Treatment of Peri-Implant Bone Defects In Vivo. Stem Cells Int. 2017;2017:3548435. doi: 10.1155/2017/3548435. Epub 2017 Aug 16.
PubMed 28951742
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hyaluronic Acid in Addition to Xenograft Material in Treatment Peri-implant Bony Defects in Immediate Implant Placement Within Maxillary Esthetic Zone
- ClinicalTrials.gov ID
- NCT06783517
- Acronym / sponsor ID
- A0104023OM
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 20 Jan 2025 (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.
Study design:
The present study will be carried out on twenty patients selected from the department of Oral Medicine, Periodontology, Oral Diagnosis and Radiology, Faculty of Dentistry, Mansoura University for replacement of non restorable maxillary anterior and/or premolar teeth within esthetic zone by immediate implant divided into two groups. A written informed consent will be obtained from all patients before their participation in this study.
Evaluation of study:
All patients will be seen at regular time interval for evaluation at the visit of surgical intervention , follow up of clinical parameter will be recorded monthly then three , six months postoperative and six month after loading(with twelve month follow up study).
- Clinical evaluation: Implant stability evaluation Soft tissue evaluation
- Radiographic evaluation:
- Marginal bone loss(MBL).
Detailed description
Study design:
The present study will be carried out on two groups of patients.
A-Patients Sample:
Twenty patients selected from the department of Oral Medicine, Periodontology, Oral Diagnosis and Radiology, Faculty of Dentistry, Mansoura University for replacement of non restorable maxillary anterior and/or premolar teeth within esthetic zone by immediate implant. A written informed consent will be obtained from all patients before their participation in this study.
- Group (1): Comprised of ten patients with hopeless non-restorable maxillary anterior and/or premolar tooth within the esthetic zone will be extracted and replaced by an immediately placed dental implant in conjunction with Bovine bone mineral graft material( cerabone®,Botiss biomaterial) followed by healing abutment. ii. Group (2): Comprised of ten patients with hopeless non-restorable maxillary anterior and/or premolar tooth within the esthetic zone will be extracted and replaced by an immediately placed dental implant in conjunction with Bovine bone mineral with sodium hyaluronate graft material (cerabone®plus,Botiss biomaterial) followed by healing abutment.
Inclusion criteria:
- Patients who are medically free from any systemic diseases.
- Patients with good oral hygiene and regular maintenance.
- Age of patients will be >20 years.
- Presence of at least single non restorable maxillary anterior and/or premolar tooth due to caries, root resorption, endodontic failure, root fracture or tooth with open apex.
- No acute infection is present within both periodontal and/or peri-apical area within the tooth of concern and/or adjacent teeth.
- Patients with extraction socket type I.
- Free from history of clenching, tapping and bruxism.
- Patients prepared to co-operate and comply with the follow-up and maintenance program.
Exclusion criteria:
- Patients taking medications known to influence bone metabolism ( such as heparin, warfarin, corticosteroid).
- Smoking and alcoholic patients.
- History of radiation in the head and neck region.
- Insufficient interocclusal distance for implant placement and restoration.
- Patient with lack of stable posterior occlusion.
- Pregnant, lactating and post-menopausal female patients. Complete medical history, dental history will be taken to all of patients in the study.
Materials:
- Dental Implants: Conventional 2 pieces screw type dental implants. B. Bone substitute: Bovine bone graft material (cerabone®,Botiss biomaterial) and Bovine bone substitute with sodium hyaluronate graft material (cerabone®plus,Botiss biomaterial).
- Trephine bur: to create intentional bony defect in experimental rabbits. D. Ostell: to measure the primary and secondary stability of the implant.
Methods:
- Pre-operative measurements:
- Photographs: for all items under research. B. Preoperative Radiographs: CBCT will be taken for clinical patients before treatment.
- Antibiotic administration for both patients and rabbits before implant placement.
- Surgical Procedures:
- Clinical sample (patients) :
- Atraumatic removal of remaining root or tooth will be performed using periotome, appropriate forceps and elevators in an attempt to preserve the buccal plate of bone and soft tissue.
- Implant will be placed in fresh socket using implant motor with saline coolant after curettage and its size is determined according to pre-operative CBCT within both groups.
- Group (1): Bovine bone graft (cerabone®,Botiss biomaterial)will be added to the implant.
- Group (2): Bovine bone substitute with sodium hyaluronate graft (cerabone®plus,Botiss biomaterial) will be added to the implant.
- followed by healing abutment.
- Post-operative care: The patients will be instructed to consume soft food for eight weeks Patients will be maintained on amoxicillin twice a day for six days and Ibuprofen 400mg 2 to 4 times daily
- loading will begin at three to four months from surgical intervention. 3-Evaluation of study:
- Patients evaluation:
All patients will be seen at regular time interval for evaluation at the visit of surgical intervention , follow up of clinical parameter will be recorded monthly then three , six months postoperative and six month after loading(with twelve month follow up study).
- Clinical evaluation:
- Soft tissue evaluation: This will be done in both groups where, soft tissue evaluation will be done using probing depth(PD) and pink esthetic score (PES) around dental implant. ii. Implant stability evaluation: Using Osstell implant stability will be assessed in both groups soon after implant placement to assess primary implant stability then three , six and twelve months after surgery to assess secondary implant stability.
- Radiographic evaluation: Radiographic assessment will be held preoperative ,six and twelve months after implant placement for evaluation of:
- Marginal bone loss(MBL). Statistical Analysis: All data will be collected and statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate dental implant with cerabone® | Experimental | Procedure: ceraboneComprised of ten patients with hopeless non-restorable maxillary anterior and/or premolar tooth within the esthetic zone will be extracted and replaced by an immediately placed dental implant in conjunction with Bovine bone mineral graft material( cerabone®,Botiss biomaterial) followed by healing abutment. |
| immediate dental implant with cerabone plus® | Active comparator | Procedure: cerabone®plusComprised of ten patients with hopeless non-restorable maxillary anterior and/or premolar tooth within the esthetic zone will be extracted and replaced by an immediately placed dental implant in conjunction with Bovine bone mineral with sodium hyaluronate graft material (cerabone®plus,Botiss biomaterial) followed by healing abutment. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- • Patients who are medically free from any systemic diseases.
Key exclusion criteria (6 listed)
- • Patients taking medications known to influence bone metabolism ( such as heparin, warfarin, corticosteroid).
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 |
|---|---|---|
| ceraboneAtraumatic removal of remaining root or tooth will be performed Implant will be placed in fresh socket Bovine bone graft (cerabone®,Botiss biomaterial) will be added to the implant | Procedure or surgery | immediate dental implant with cerabone® |
| cerabone®plusAtraumatic removal of remaining root or tooth will be performed Implant will be placed in fresh socket Bovine bone substitute with sodium hyaluronate graft (cerabone®plus,Botiss biomaterial) will be added to the implant | Procedure or surgery | immediate dental implant with cerabone plus® |
Primary outcome
radiographic marginal bone change
Time frame: preoperative , at time implant placement, six and twelve months after implant placement
Radiographic cone beam tomography (CBCT) assessment will be held preoperative ,at time implant placement, six and twelve months after implant placement
Implant stability evaluation
Time frame: at time of placement, three , six months after surgery to assess secondary implant stability
Using Osstell implant stability will be assessed in both groups soon after implant placement to assess primary implant stability then three , six months after surgery to assess secondary implant stability
1 secondary outcome
Soft tissue evaluation
Time frame: monthly then three , six months postoperative and six month after loading
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 20 Jan 2025.
- Background: PubMed 29707988Peric Kacarevic Z, Kavehei F, Houshmand A, Franke J, Smeets R, Rimashevskiy D, Wenisch S, Schnettler R, Jung O, Barbeck M. Purification processes of xenogeneic bone substitutes and their impact on tissue reactions and regeneration. Int J Artif Organs. 2018 Nov;41(11):789-800. doi: 10.1177/0391398818771530. Epub 2018 Apr 29.
- Background: PubMed 27382506Dos Santos PL, de Molon RS, Queiroz TP, Okamoto R, de Souza Faloni AP, Gulinelli JL, Luvizuto ER, Garcia IR Jr. Evaluation of bone substitutes for treatment of peri-implant bone defects: biomechanical, histological, and immunohistochemical analyses in the rabbit tibia. J Periodontal Implant Sci. 2016 Jun;46(3):176-96. doi: 10.5051/jpis.2016.46.3.176. Epub 2016 Jun 28.
- Background: PubMed 31545532Cohen DJ, Scott KM, Kulkarni AN, Wayne JS, Boyan BD, Schwartz Z. Acellular mineralized allogenic block bone graft does not remodel during the 10 weeks following concurrent implant placement in a rabbit femoral model. Clin Oral Implants Res. 2020 Jan;31(1):37-48. doi: 10.1111/clr.13544. Epub 2019 Oct 10.
- Background: PubMed 35683136Kyyak S, Blatt S, Wiesmann N, Smeets R, Kaemmerer PW. Hyaluronic Acid with Bone Substitutes Enhance Angiogenesis In Vivo. Materials (Basel). 2022 May 27;15(11):3839. doi: 10.3390/ma15113839.
- Background: PubMed 21254389Raines AL, Sunwoo M, Gertzman AA, Thacker K, Guldberg RE, Schwartz Z, Boyan BD. Hyaluronic acid stimulates neovascularization during the regeneration of bone marrow after ablation. J Biomed Mater Res A. 2011 Mar 1;96(3):575-83. doi: 10.1002/jbm.a.33012. Epub 2011 Jan 10.
- Background: PubMed 26284973Zhao N, Wang X, Qin L, Guo Z, Li D. Effect of molecular weight and concentration of hyaluronan on cell proliferation and osteogenic differentiation in vitro. Biochem Biophys Res Commun. 2015 Sep 25;465(3):569-74. doi: 10.1016/j.bbrc.2015.08.061. Epub 2015 Aug 15.
- Background: PubMed 9799448Pilloni A, Bernard GW. The effect of hyaluronan on mouse intramembranous osteogenesis in vitro. Cell Tissue Res. 1998 Nov;294(2):323-33. doi: 10.1007/s004410051182.
- Background: PubMed 28731160Guo J, Guo S, Wang Y, Yu Y. Adipose-derived stem cells and hyaluronic acid based gel compatibility, studied in vitro. Mol Med Rep. 2017 Oct;16(4):4095-4100. doi: 10.3892/mmr.2017.7055. Epub 2017 Jul 21.
- Background: PubMed 7742090Sasaki T, Watanabe C. Stimulation of osteoinduction in bone wound healing by high-molecular hyaluronic acid. Bone. 1995 Jan;16(1):9-15. doi: 10.1016/s8756-3282(94)00001-8.
- Background: PubMed 10328647Pirnazar P, Wolinsky L, Nachnani S, Haake S, Pilloni A, Bernard GW. Bacteriostatic effects of hyaluronic acid. J Periodontol. 1999 Apr;70(4):370-4. doi: 10.1902/jop.1999.70.4.370.
- Background: PubMed 21266161Kawano M, Ariyoshi W, Iwanaga K, Okinaga T, Habu M, Yoshioka I, Tominaga K, Nishihara T. Mechanism involved in enhancement of osteoblast differentiation by hyaluronic acid. Biochem Biophys Res Commun. 2011 Feb 25;405(4):575-80. doi: 10.1016/j.bbrc.2011.01.071. Epub 2011 Jan 23.
- Background: PubMed 11791922Grigolo B, Lisignoli G, Piacentini A, Fiorini M, Gobbi P, Mazzotti G, Duca M, Pavesio A, Facchini A. Evidence for redifferentiation of human chondrocytes grown on a hyaluronan-based biomaterial (HYAff 11): molecular, immunohistochemical and ultrastructural analysis. Biomaterials. 2002 Feb;23(4):1187-95. doi: 10.1016/s0142-9612(01)00236-8.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cerabone and cerabone®plus in people with Effect of Putty Form Bone Graft in Immediate Implant Placment, run by Mansoura 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 8 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: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2025. 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiographic marginal bone change (time frame: preoperative , at time implant placement, six and twelve months after implant placement). The study lists 2 primary outcomes in all. 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 NCT06783517, 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 20 Jan 2025.