Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657521
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-23
Brief Title:
Osteoimplant and Dental Implants Stability
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Influence of the Osteoimplant Vitamin Complex on the Stability of Dental Implants Randomized Double-blind Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OIMP
Brief Summary:
Based on the scientific evidence the relevance of this subject we consider this study to be justified the general or specific objective of which is as follows
To evaluate the effect of the administration of Osteoimplant and Osteoimplant Complex as a food supplement in obtaining implant stability and in the healing of dental implant surgery
As secondary objectives we will also evaluate the effect of Osteoimplant and Osteoimplant Complex on pain postoperative inflammation and soft tissue healing
The sample will consist of 60 patients The sample will be randomly divided into 2 groups using a randomisation table generated by a statistical programme For blinding neither the patient nor the operator shall be aware of the group to which each patient belongs To ensure blinding medication will be delivered in sealed opaque envelopes Patients shall be assigned to one of the following groups
Group I 30 patients prescribed to take Osteoimplant Complex on the following schedule 2 tablets per day starting 5 days before implant placement and 1 tablet per day of Osteimplant for 2 months after implant placement
Group II 30 patients who were prescribed placebo with the following regimen 2 tablets per day starting 5 days before implant placement and 1 tablet per day for 2 months after implant placement
To evaluate the effect of the administration of Osteoimplant and Osteoimplant Complex as a food supplement in obtaining implant stability and in the healing of dental implant surgery
As secondary objectives we will also evaluate the effect of Osteoimplant and Osteoimplant Complex on pain postoperative inflammation and soft tissue healing
The sample will consist of 60 patients The sample will be randomly divided into 2 groups using a randomisation table generated by a statistical programme For blinding neither the patient nor the operator shall be aware of the group to which each patient belongs To ensure blinding medication will be delivered in sealed opaque envelopes Patients shall be assigned to one of the following groups
Group I 30 patients prescribed to take Osteoimplant Complex on the following schedule 2 tablets per day starting 5 days before implant placement and 1 tablet per day of Osteimplant for 2 months after implant placement
Group II 30 patients who were prescribed placebo with the following regimen 2 tablets per day starting 5 days before implant placement and 1 tablet per day for 2 months after implant placement
Detailed Description:
Based on the scientific evidence the relevance of this subject we consider this study to be justified the general or specific objective of which is as follows
To evaluate the effect of the administration of Osteoimplant and Osteoimplant Complex as a food supplement in obtaining implant stability and in the healing of dental implant surgery
As secondary objectives we will also evaluate the effect of Osteoimplant and Osteoimplant Complex on pain postoperative inflammation and soft tissue healing
The sample will consist of 60 patients The sample will be randomly divided into 2 groups using a randomisation table generated by a statistical programme For blinding neither the patient nor the operator shall be aware of the group to which each patient belongs To ensure blinding medication will be delivered in sealed opaque envelopes Patients shall be assigned to one of the following groups
Group I 30 patients prescribed to take Osteoimplant Complex on the following schedule 2 tablets per day starting 5 days before implant placement and 1 tablet per day of Osteimplant for 2 months after implant placement
Group II 30 patients who were prescribed placebo with the following regimen 2 tablets per day starting 5 days before implant placement and 1 tablet per day for 2 months after implant placement
31 Study design Our study is a double-blind randomised clinical trial RCT to evaluate the stability of the implants in the different phases of treatment at the time of insertion primary stability at 8 and 12 weeks secondary stability Postoperative pain and swelling will also be studied
Composition of nutritional supplements
The preoperative nutritional supplement corresponds to Osteoimplant Complex and is composed of vitamin C 485 mg coenzyme Q10 413 mg Zinc 35 mg beta-carotene 10 25 mg bioflavonoids citrus 60 2083 mg vitamin E and magnesium 15 mg
The post-operative nutritional supplement corresponds to Osteoimplant and is composed of Ovocet collagen 350 mg calcium 300 mg vitamin D3 100IUmg magnesium 8 mg
Patients Conceptual or target population Patients with partial or total single tooth edentulism requiring rehabilitation with intraosseous implants
Study or accessible population The patients who will form part of our study will be those who attend the Masters Degree in Oral Surgery and Implantology of the Faculty of Dentistry of the University of Granada requesting dental implants for their rehabilitation
All patients will undergo a clinical history and subsequent clinical examination The clinical history will consist of an anamnesis where the patients personal details will be collected name age sex profession address and telephone number as well as family history illnesses suffered previous surgical interventions drug allergies and current treatment Subsequently an intraoral and extraoral examination will be carried out consisting of inspection and palpation of the bucco-facial territory
To complement our examination and make a correct diagnosis all patients will undergo a radiological study as a step prior to surgery which will always consist of an orthopantomography the usual projection for this type of intervention with which a correct diagnosis can be made In addition we will complete the study with a CBCT in order to assess three-dimensionally the relationship with anatomical structures and the availability of bone
Once the diagnosis has been correctly made the patient will be informed both orally and in writing of the possible complications that may arise in this type of surgery The following inclusion and exclusion criteria will be applied to the target population for participation in the study
Inclusion criteria
Patients presenting with unitary or partial edentulism
Age Between 18-75 years
Anaesthetic risk ASA I-II
Patients who do not abuse alcohol drugs or chronic smoking 10 cigarettesday
Patients with adequate periodontal status 10 plaque index and bleeding index
Absence of drug allergies that could compromise our study
Absence of allergy to any of the components of Osteoimplant and Osteimplant Complex
Signed informed consent
Exclusion criteria
Age not between 18-75 years old
Pregnant or breastfeeding women
Chronic smokers 10 cigarettesday
Patients with decompensated metabolic disease
Poor periodontal status 10 plaque index and bleeding index
Patients allergic to any of the components of Osteoimplant and Osteimplant Complex
Patients undergoing treatment with drugs that could affect the bone regeneration process such as chemotherapy drugs bisphosphonates corticosteroids or immunosuppressants
Patients with metabolic bone diseases or who have undergone radiotherapy in the last five years
Patients with hypercalcaemia or a tendency to hypercalcification taking vitamin D or calcium supplements
Patients with a history of renal colic
Patients who are not going to undergo nephrotic colic 1 Surgical Protocol First of all the patient rinses with 012 chlorhexidine After 1 minute the area to be implanted is anaesthetised using a truncal block or infiltrative technique with 4 articaine together with epinephrine A transcrestal or paracrestal incision is made depending on the case and the mucoperiosteal flap is detached Once detached the position of the implant will be determined thanks to the in situ visualisation of the bone thickness and the previous CBCT study of each patient Subsequently the drilling sequence is determined by the company itself Once the implant bed has been created we will proceed to insert the implant with a torque of at least 30-45N At this point the first stability measurement will be taken then the cover screw will be placed and the flap and suture will be repositioned The patient will be reviewed and given a series of postoperative guidelines in physical format which it is essential to follow for a correct result of our surgery
All implants will be placed following the same surgical protocol and in strict compliance with the implant manufacturers instructions regarding the drilling protocol associated with the patients bone quality
Once the implants are placed stability measurements shall be taken with the Osstell ISQ and the stability levels of the implants shall be evaluated at different stages of treatment by performing the following measurements
1 First measurement after implant placement surgery We will evaluate the primary stability
2 Second measurement at 8 weeks to determine the evolution of osseointegration throughout the healing process of our implants
3 Third measurement at 12 weeks to assess the evolution of osseointegration again before subjecting the implant to occlusal loads
Prior to implant placement each patient will be assigned to a study group where depending on their assignment they will receive either placebo or the drug in question
Preoperative phase
Group I prescribed to take Osteoimplant Complex 2 every 24 hours 5 days prior to surgery
Group II prescribed to take placebo 2 every 24 hours 5 days prior to surgery
Post-operative phase
Group I prescribed to take Osteoimplant 1 every 24 hours for 8 weeks after surgery
Group II prescribed placebo 1 every 24 hours for 8 weeks after surgery In both groups an antibiotic treatment of amoxicillin 500 mg 1 every 8 hours for 5 days is administered In case of penicillin allergy the drug of choice will be clindamycin 300 mg 1 every 8 hours for 5 days as well as an analgesic and anti-inflammatory treatment ibuprofen 400 mg 1 every 8 hours for 2 days from the third day on demand As rescue medication paracetamol 1 g
To evaluate the effect of the administration of Osteoimplant and Osteoimplant Complex as a food supplement in obtaining implant stability and in the healing of dental implant surgery
As secondary objectives we will also evaluate the effect of Osteoimplant and Osteoimplant Complex on pain postoperative inflammation and soft tissue healing
The sample will consist of 60 patients The sample will be randomly divided into 2 groups using a randomisation table generated by a statistical programme For blinding neither the patient nor the operator shall be aware of the group to which each patient belongs To ensure blinding medication will be delivered in sealed opaque envelopes Patients shall be assigned to one of the following groups
Group I 30 patients prescribed to take Osteoimplant Complex on the following schedule 2 tablets per day starting 5 days before implant placement and 1 tablet per day of Osteimplant for 2 months after implant placement
Group II 30 patients who were prescribed placebo with the following regimen 2 tablets per day starting 5 days before implant placement and 1 tablet per day for 2 months after implant placement
31 Study design Our study is a double-blind randomised clinical trial RCT to evaluate the stability of the implants in the different phases of treatment at the time of insertion primary stability at 8 and 12 weeks secondary stability Postoperative pain and swelling will also be studied
Composition of nutritional supplements
The preoperative nutritional supplement corresponds to Osteoimplant Complex and is composed of vitamin C 485 mg coenzyme Q10 413 mg Zinc 35 mg beta-carotene 10 25 mg bioflavonoids citrus 60 2083 mg vitamin E and magnesium 15 mg
The post-operative nutritional supplement corresponds to Osteoimplant and is composed of Ovocet collagen 350 mg calcium 300 mg vitamin D3 100IUmg magnesium 8 mg
Patients Conceptual or target population Patients with partial or total single tooth edentulism requiring rehabilitation with intraosseous implants
Study or accessible population The patients who will form part of our study will be those who attend the Masters Degree in Oral Surgery and Implantology of the Faculty of Dentistry of the University of Granada requesting dental implants for their rehabilitation
All patients will undergo a clinical history and subsequent clinical examination The clinical history will consist of an anamnesis where the patients personal details will be collected name age sex profession address and telephone number as well as family history illnesses suffered previous surgical interventions drug allergies and current treatment Subsequently an intraoral and extraoral examination will be carried out consisting of inspection and palpation of the bucco-facial territory
To complement our examination and make a correct diagnosis all patients will undergo a radiological study as a step prior to surgery which will always consist of an orthopantomography the usual projection for this type of intervention with which a correct diagnosis can be made In addition we will complete the study with a CBCT in order to assess three-dimensionally the relationship with anatomical structures and the availability of bone
Once the diagnosis has been correctly made the patient will be informed both orally and in writing of the possible complications that may arise in this type of surgery The following inclusion and exclusion criteria will be applied to the target population for participation in the study
Inclusion criteria
Patients presenting with unitary or partial edentulism
Age Between 18-75 years
Anaesthetic risk ASA I-II
Patients who do not abuse alcohol drugs or chronic smoking 10 cigarettesday
Patients with adequate periodontal status 10 plaque index and bleeding index
Absence of drug allergies that could compromise our study
Absence of allergy to any of the components of Osteoimplant and Osteimplant Complex
Signed informed consent
Exclusion criteria
Age not between 18-75 years old
Pregnant or breastfeeding women
Chronic smokers 10 cigarettesday
Patients with decompensated metabolic disease
Poor periodontal status 10 plaque index and bleeding index
Patients allergic to any of the components of Osteoimplant and Osteimplant Complex
Patients undergoing treatment with drugs that could affect the bone regeneration process such as chemotherapy drugs bisphosphonates corticosteroids or immunosuppressants
Patients with metabolic bone diseases or who have undergone radiotherapy in the last five years
Patients with hypercalcaemia or a tendency to hypercalcification taking vitamin D or calcium supplements
Patients with a history of renal colic
Patients who are not going to undergo nephrotic colic 1 Surgical Protocol First of all the patient rinses with 012 chlorhexidine After 1 minute the area to be implanted is anaesthetised using a truncal block or infiltrative technique with 4 articaine together with epinephrine A transcrestal or paracrestal incision is made depending on the case and the mucoperiosteal flap is detached Once detached the position of the implant will be determined thanks to the in situ visualisation of the bone thickness and the previous CBCT study of each patient Subsequently the drilling sequence is determined by the company itself Once the implant bed has been created we will proceed to insert the implant with a torque of at least 30-45N At this point the first stability measurement will be taken then the cover screw will be placed and the flap and suture will be repositioned The patient will be reviewed and given a series of postoperative guidelines in physical format which it is essential to follow for a correct result of our surgery
All implants will be placed following the same surgical protocol and in strict compliance with the implant manufacturers instructions regarding the drilling protocol associated with the patients bone quality
Once the implants are placed stability measurements shall be taken with the Osstell ISQ and the stability levels of the implants shall be evaluated at different stages of treatment by performing the following measurements
1 First measurement after implant placement surgery We will evaluate the primary stability
2 Second measurement at 8 weeks to determine the evolution of osseointegration throughout the healing process of our implants
3 Third measurement at 12 weeks to assess the evolution of osseointegration again before subjecting the implant to occlusal loads
Prior to implant placement each patient will be assigned to a study group where depending on their assignment they will receive either placebo or the drug in question
Preoperative phase
Group I prescribed to take Osteoimplant Complex 2 every 24 hours 5 days prior to surgery
Group II prescribed to take placebo 2 every 24 hours 5 days prior to surgery
Post-operative phase
Group I prescribed to take Osteoimplant 1 every 24 hours for 8 weeks after surgery
Group II prescribed placebo 1 every 24 hours for 8 weeks after surgery In both groups an antibiotic treatment of amoxicillin 500 mg 1 every 8 hours for 5 days is administered In case of penicillin allergy the drug of choice will be clindamycin 300 mg 1 every 8 hours for 5 days as well as an analgesic and anti-inflammatory treatment ibuprofen 400 mg 1 every 8 hours for 2 days from the third day on demand As rescue medication paracetamol 1 g
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None