Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513039
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-14
Brief Title:
Evaluation of Erythropoietin on Alveolar Ridge Preservation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Erythropoietin on Alveolar Ridge Preservation A Randomized Controlled Clinical Trial With Histomorphometric Assessment
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
regenerative materials would help in decreasing post-extraction resorption in sites indicated for placement of a conventional bridge or prosthetically driven implant Erythropoietin EPO is a growth factor that promotes angiogenesis and bone regeneration by stimulating osteoblastic differentiation and by inhibiting osteoclastic resorption Post-extraction alveolar ridge resorption creates morphological and volumetric changes These changes can be considered of clinical value that may threaten the placement of a conventional bridge or an implant-supported crown Atwood et al 1 in a cephalometric study categorized factors influencing the rate of alveolar ridge resorption into 4 types anatomic metabolic functional and prosthetic As stated by Tan et al 2 in a systematic review of alveolar hard and soft tissue dimensional changes in humans post-extraction they found that alveolar ridge resorption occurs to a greater extent in a horizontal direction than vertical Therefore alveolar ridge preservation ARP procedures were introduced in an attempt to prevent hard and soft tissue dimensional changes following extraction
Detailed Description:
II Aim of the study
To assess the efficiency of Erythropoietin in alveolar ridge preservation
1 Objectives
Primary objective
Dimensional changes of the ridge clinically and radiographically
Secondary objective
1 Postoperative pain
2 Postoperative wound healing
3 Histomorphometric analysis of the bone regeneration patterns of the extraction sockets
III Materials and Methods
1 Study design and patient selection
It is a randomized controlled clinical trial Patients will be selected from the outpatient clinic of the Department of Oral Medicine and Periodontology-Ain Shams University and the British University of Egypt All patients will sign an informed consent about the details of the surgery according to the Ethical Committee Ain Shams University
2 Sample size
The sample size was estimated based on assuming confidence level 95 and study power 80 Pandya et al 29 reported that the Collagen percentage was 2106 in EPO treated sockets while it was 106 in non-treated sockets the average Standard deviation was 06n The minimum sample size was calculated to be 5 extraction sockets per group This was increased to 7 sockets to make up for lost to follow-up cases The total sample size number of groups number per group 37 21 sockets The sample size was collected by G power 3010
3 Eligibility criteria
Inclusion criteria
1 Age range 18-40
2 Hopeless teeth indicated for extraction such as root fractures caries internal root resorption external root resorption endodontic failures
3 Systemically free patients using Cornell Medical Index-Health Questionnaire 36
4 Patients diagnosed with intact surrounding alveolar bone socket type I 37
5 Maxillary anterior teeth andor premolars indicated for extraction
6 Enough zone of keratinized tissue 2 mm
Exclusion criteria
1 Smokers
2 Occlusal trauma at the site of the graft
3 Pregnancy and lactation
4 Bad compliance with the plaque control instructions following initial therapy
4 Interventions
Pre-surgical phase
Patients will be initially examined All patients will receive oral hygiene instructions using roll technique with a soft-bristled toothbrush and interdental floss and phase I therapy using an ultrasonic device if necessary At baseline intraoral periapical radiographs clinical periodontal measurements including plaque Index 38 bleeding on probing BOP 38 probing depth PD 38 and clinical attachment level CAL 38 will be recorded at teeth adjacent to the extraction socket area using a UNC periodontal probe 38
Impressions will be taken using Alginate impression material before the extraction day Diagnostic casts will be made for the fabrication of a customized stent to standardize the measurements of marginal crestal bone levels at baseline and 4 months post-extraction 39
Surgical preparation of Extraction socket
1 After anesthetizing the surgical field with local anesthesia 4 Articaine 1 100 000 epinephrine An atraumatic extraction procedure will be performed by cutting the periodontal ligaments gently to preserve the buccal plate of bone using periotome and forceps
2 The socket will be irrigated with saline and curetted from any granulation tissue following extraction then the buccal and lingual plate of bone will be checked for absence of any fenestration or dehiscence using UNC periodontal probe
3 Computer-generated randomization will be used to randomly divide the sockets into three groups Group I Extraction sockets filled with CS β-GPgelatin hydrogels loaded EPO until the crestal level
Group II extraction sockets filled with CS β-GPgelatin hydrogels alone until the crestal level
Group III Natural healing socket control group
4 In the three groups the flaps will be sutured with criss-cross horizontal mattress technique with polypropylene 5-0
Implant placement Surgery
Patients will return for a follow-up examination at 4 months and implant placement
1 After anesthetizing the surgical field with local anesthesia 4 Articaine 1 100 000 epinephrine a papillary sparing will be incised using Bard-Parker scalpel carrying blade number 15C a crestal flap will be elevated by Molt number 5 mucoperiosteal elevator
2 The first drill will be a trephine bur to collect a core bone biopsy the collected bone will be preserved in a diluted formaldehyde solution to fix the sample to perform the histomorphometry
3 Sequential twist drills will be used until the final drill following the implant manufacturer instructions
4 In the three groups the flaps will be sutured with criss-cross horizontal mattress technique suture type using 5-0 polypropylene sutures
Postoperative care instruction and medication of both surgeries
Patients will be instructed to rinse twice daily with a 012 chlorhexidine gluconate solution for 2 weeks and the sutures will be removed after 2 weeks later
Analgesic and antibiotic drugs were prescribed after the surgical procedure Ibobrufen 400 mg will be prescribed upon patients need with a maximum dose 2400mg per day for pain relief 40 Amoxicillin 500 mg every 12 hours for 7 days or clindamycin 300 mg every 8 hours for 5 days for patients having a penicillin allergy three times per day for infection control 41
5 Assessment
A Clinical assessment
1 Dimensional changes width changes will be measured using bone caliper at baseline immediately following tooth extraction and 4 months postoperatively 42
2 Postoperative Pain level Pain score will be reported by the patient directly through Visual Analogue Scale score between 0 and 10 0 no pain 1 minimal pain 5 moderate pain 10 severe pain VAS will be recorded at day 14 post-extraction 43 Post-operative pain was assessed indirectly by mean consumption of analgesics for 7 days postoperatively will be recorded in milligrams44
3 Postoperative wound healing Wound healing will be recorded the 1st and 2 weeks postoperatively through Landry Wound Healing Index LWHI 45 which evaluates the extraction site based on tissue color response to touch the marginality of the incision line and extent of the area The rating is from 1 very poor to 5 excellent
B Radiographic assessment
Dimensional changes will be measured using Cone Beam computed Tomography CBCT at baseline immediately following tooth extraction and 4 months postoperatively 42
C Histomorphometric assessment
Histological and histomorphometric assessment of bone regeneration patterns of core biopsy harvested at the re-entry surgery for implant placement 4 months post extraction using HE stains to evaluate bone trabeculae and Modified Masson Trichrome to evaluate bone maturity46
To assess the efficiency of Erythropoietin in alveolar ridge preservation
1 Objectives
Primary objective
Dimensional changes of the ridge clinically and radiographically
Secondary objective
1 Postoperative pain
2 Postoperative wound healing
3 Histomorphometric analysis of the bone regeneration patterns of the extraction sockets
III Materials and Methods
1 Study design and patient selection
It is a randomized controlled clinical trial Patients will be selected from the outpatient clinic of the Department of Oral Medicine and Periodontology-Ain Shams University and the British University of Egypt All patients will sign an informed consent about the details of the surgery according to the Ethical Committee Ain Shams University
2 Sample size
The sample size was estimated based on assuming confidence level 95 and study power 80 Pandya et al 29 reported that the Collagen percentage was 2106 in EPO treated sockets while it was 106 in non-treated sockets the average Standard deviation was 06n The minimum sample size was calculated to be 5 extraction sockets per group This was increased to 7 sockets to make up for lost to follow-up cases The total sample size number of groups number per group 37 21 sockets The sample size was collected by G power 3010
3 Eligibility criteria
Inclusion criteria
1 Age range 18-40
2 Hopeless teeth indicated for extraction such as root fractures caries internal root resorption external root resorption endodontic failures
3 Systemically free patients using Cornell Medical Index-Health Questionnaire 36
4 Patients diagnosed with intact surrounding alveolar bone socket type I 37
5 Maxillary anterior teeth andor premolars indicated for extraction
6 Enough zone of keratinized tissue 2 mm
Exclusion criteria
1 Smokers
2 Occlusal trauma at the site of the graft
3 Pregnancy and lactation
4 Bad compliance with the plaque control instructions following initial therapy
4 Interventions
Pre-surgical phase
Patients will be initially examined All patients will receive oral hygiene instructions using roll technique with a soft-bristled toothbrush and interdental floss and phase I therapy using an ultrasonic device if necessary At baseline intraoral periapical radiographs clinical periodontal measurements including plaque Index 38 bleeding on probing BOP 38 probing depth PD 38 and clinical attachment level CAL 38 will be recorded at teeth adjacent to the extraction socket area using a UNC periodontal probe 38
Impressions will be taken using Alginate impression material before the extraction day Diagnostic casts will be made for the fabrication of a customized stent to standardize the measurements of marginal crestal bone levels at baseline and 4 months post-extraction 39
Surgical preparation of Extraction socket
1 After anesthetizing the surgical field with local anesthesia 4 Articaine 1 100 000 epinephrine An atraumatic extraction procedure will be performed by cutting the periodontal ligaments gently to preserve the buccal plate of bone using periotome and forceps
2 The socket will be irrigated with saline and curetted from any granulation tissue following extraction then the buccal and lingual plate of bone will be checked for absence of any fenestration or dehiscence using UNC periodontal probe
3 Computer-generated randomization will be used to randomly divide the sockets into three groups Group I Extraction sockets filled with CS β-GPgelatin hydrogels loaded EPO until the crestal level
Group II extraction sockets filled with CS β-GPgelatin hydrogels alone until the crestal level
Group III Natural healing socket control group
4 In the three groups the flaps will be sutured with criss-cross horizontal mattress technique with polypropylene 5-0
Implant placement Surgery
Patients will return for a follow-up examination at 4 months and implant placement
1 After anesthetizing the surgical field with local anesthesia 4 Articaine 1 100 000 epinephrine a papillary sparing will be incised using Bard-Parker scalpel carrying blade number 15C a crestal flap will be elevated by Molt number 5 mucoperiosteal elevator
2 The first drill will be a trephine bur to collect a core bone biopsy the collected bone will be preserved in a diluted formaldehyde solution to fix the sample to perform the histomorphometry
3 Sequential twist drills will be used until the final drill following the implant manufacturer instructions
4 In the three groups the flaps will be sutured with criss-cross horizontal mattress technique suture type using 5-0 polypropylene sutures
Postoperative care instruction and medication of both surgeries
Patients will be instructed to rinse twice daily with a 012 chlorhexidine gluconate solution for 2 weeks and the sutures will be removed after 2 weeks later
Analgesic and antibiotic drugs were prescribed after the surgical procedure Ibobrufen 400 mg will be prescribed upon patients need with a maximum dose 2400mg per day for pain relief 40 Amoxicillin 500 mg every 12 hours for 7 days or clindamycin 300 mg every 8 hours for 5 days for patients having a penicillin allergy three times per day for infection control 41
5 Assessment
A Clinical assessment
1 Dimensional changes width changes will be measured using bone caliper at baseline immediately following tooth extraction and 4 months postoperatively 42
2 Postoperative Pain level Pain score will be reported by the patient directly through Visual Analogue Scale score between 0 and 10 0 no pain 1 minimal pain 5 moderate pain 10 severe pain VAS will be recorded at day 14 post-extraction 43 Post-operative pain was assessed indirectly by mean consumption of analgesics for 7 days postoperatively will be recorded in milligrams44
3 Postoperative wound healing Wound healing will be recorded the 1st and 2 weeks postoperatively through Landry Wound Healing Index LWHI 45 which evaluates the extraction site based on tissue color response to touch the marginality of the incision line and extent of the area The rating is from 1 very poor to 5 excellent
B Radiographic assessment
Dimensional changes will be measured using Cone Beam computed Tomography CBCT at baseline immediately following tooth extraction and 4 months postoperatively 42
C Histomorphometric assessment
Histological and histomorphometric assessment of bone regeneration patterns of core biopsy harvested at the re-entry surgery for implant placement 4 months post extraction using HE stains to evaluate bone trabeculae and Modified Masson Trichrome to evaluate bone maturity46
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