Evaluation of Hyaluronic Acid in Addition to Xenograft in Immediate Implant Placement Within Maxillary Esthetic Zone
NCT ID: NCT06783517
Last Updated: 2025-01-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-10-30
Study Completion Date
2025-05-30
Brief Summary
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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).
1. Clinical evaluation:
Implant stability evaluation Soft tissue evaluation
2. Radiographic evaluation:
* Marginal bone loss(MBL).
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).
1. Clinical evaluation:
Implant stability evaluation Soft tissue evaluation
2. Radiographic evaluation:
* Marginal bone loss(MBL).
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Detailed Description
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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.
i. 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:
A. 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).
C. Trephine bur: to create intentional bony defect in experimental rabbits. D. Ostell: to measure the primary and secondary stability of the implant.
Methods:
1. Pre-operative measurements:
A. Photographs: for all items under research. B. Preoperative Radiographs: CBCT will be taken for clinical patients before treatment.
C. Antibiotic administration for both patients and rabbits before implant placement.
2. Surgical Procedures:
1\. 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:
A. 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).
1. Clinical evaluation:
i. 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.
2. 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.
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.
i. 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:
A. 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).
C. Trephine bur: to create intentional bony defect in experimental rabbits. D. Ostell: to measure the primary and secondary stability of the implant.
Methods:
1. Pre-operative measurements:
A. Photographs: for all items under research. B. Preoperative Radiographs: CBCT will be taken for clinical patients before treatment.
C. Antibiotic administration for both patients and rabbits before implant placement.
2. Surgical Procedures:
1\. 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:
A. 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).
1. Clinical evaluation:
i. 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.
2. 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.
Conditions
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Effect of Putty Form Bone Graft in Immediate Implant Placment
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Study Groups
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immediate dental implant with cerabone®
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.
Group Type
EXPERIMENTAL
cerabone
Intervention Type
PROCEDURE
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
immediate dental implant with cerabone plus®
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.
Group Type
ACTIVE_COMPARATOR
cerabone®plus
Intervention Type
PROCEDURE
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
Interventions
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cerabone
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
Intervention Type
PROCEDURE
cerabone®plus
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
Intervention Type
PROCEDURE
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
20 Years
Maximum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Mansoura University
OTHER
Sponsor Role
lead
Responsible Party
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Rabia Mohamad Dakhil
M.Sc.- Master Degree of Oral Medicine & Clinical Periodontology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Mansoura university
Egypt, Mansora, Egypt
Site Status
Countries
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Egypt
References
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Noelken R, Moergel M, Pausch T, Kunkel M, Wagner W. Clinical and esthetic outcome with immediate insertion and provisionalization with or without connective tissue grafting in presence of mucogingival recessions: A retrospective analysis with follow-up between 1 and 8 years. Clin Implant Dent Relat Res. 2018 Jun;20(3):285-293. doi: 10.1111/cid.12595. Epub 2018 Mar 24.
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Mazzocco F, Jimenez D, Barallat L, Paniz G, Del Fabbro M, Nart J. Bone volume changes after immediate implant placement with or without flap elevation. Clin Oral Implants Res. 2017 Apr;28(4):495-501. doi: 10.1111/clr.12826. Epub 2016 Mar 14.
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Koutouzis T, Adeinat B, Ali A. The influence of abutment macro-design on clinical and radiographic peri-implant tissue changes for guided, placed, and restored implants: A 1-year randomized controlled trial. Clin Oral Implants Res. 2019 Sep;30(9):882-891. doi: 10.1111/clr.13493. Epub 2019 Jun 24.
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Fuentealba R, Jofre J. Esthetic failure in implant dentistry. Dent Clin North Am. 2015 Jan;59(1):227-46. doi: 10.1016/j.cden.2014.08.006. Epub 2014 Sep 26.
Reference Type
BACKGROUND
Other Identifiers
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A0104023OM
Identifier Type: -
Identifier Source: org_study_id
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NA
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NCT06151314
COMPLETED
NA
Radiographic and Histological Assessment of Autogenous Onlay Block Versus Cortical Shell on Anterior Maxilla
NCT06450535
RECRUITING
NA
Study of Two Different Putty Bone Grafts in Treatment of Intrabony Defects with the Aid of Intramarrow Penetration Technique
NCT06699043
ACTIVE_NOT_RECRUITING
NA
Clinical and Radiographic Evaluation of Natural Bovine Bone With Hyaluronic Acid on Osseointegration of Immediate Implant.
NCT07199725
COMPLETED
PHASE2/PHASE3
Computer Guided Simultaneous Implant Placement With Tri-cortical Ridge Augmentation Using Chin Cortical Bone Struts in Anterior Atrophic Maxilla: A Case Series
NCT05731063
UNKNOWN
NA
Efficacy of Different Techniques of Crestal Sinus Lifting
NCT05735613
COMPLETED
NA
Zinc Incorporated Bovine Derived- Hydroxyappatite Xenograft in Immediately Placed Implant
NCT07187609
RECRUITING
NA
The Influence of 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation
NCT06312384
ACTIVE_NOT_RECRUITING
PHASE3
Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation
NCT06457373
NOT_YET_RECRUITING
NA
Effectiveness of ALB-PRF With Two Types of Bone Grafts With Putty Form Around Immediate Dental Implants.
NCT06643468
ENROLLING_BY_INVITATION
NA
Khoury Technique Versus Titanium Reinforced PTFE Membrane in 3D Alveolar Bone Augmentation
NCT06209905
COMPLETED
NA
Immediate Implant Placement With Provisionalization Using Different Bone Grafts as a Space Filling Material in the Maxillary Esthetic Zone
NCT03741036
UNKNOWN
NA
Simultaneous Implant Placement With Vertical and Horizontal Bone Augmentation
NCT06313229
ACTIVE_NOT_RECRUITING
NA