Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347263
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-03-29
Brief Title:
Clinical and Radiographic Evaluation of Using the Entire Papilla Preservation Technique With and Without Autogenous Bone Graft and Injectable Platelet Rich Fibrin in Treatment of Periodontal Intraosseous Defects
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Clinical and Radiographic Evaluation of Using the Entire Papilla Preservation Technique With and Without Autogenous Bone Graft and Injectable Platelet Rich Fibrin in Treatment of Periodontal Intraosseous Defects A Randomized Clinical Tria
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this Clinical trial is to evaluate the clinical and radiographic outcomes of using entire papilla preservation technique with and without autogenous bone and injectable platelet rich fibrin in treatment of isolated Intrabony defects in patients with stage III periodontitis
Detailed Description:
Research objective The aim of conducting this research is the development of a newer less invasive and cost-effective surgical approaches that help in treatment of periodontal intrabony defectsDue to the shortcomings of access flap approaches another minimally invasive surgical technique which is the Entire papilla preservation technique will be used to approach the defect Also due to the short comings of using other bone substitute materials and resorbable membranes the Autogenous bone graft which is the gold standard of bone grafts and the injectable platelet rich fibrin will be used in this study
Research Procedure in brief
The study is to be conducted in the Oral Medicine and Periodontology department Faculty of Dentistry - Cairo University Egypt This study will be carried out on patients enrolled from the Outpatient Clinic of Oral Medicine and Periodontology department Faculty of Dentistry Cairo University
Eligibility criteria
I Inclusion criteria
1 Patients with healthy systemic condition
2 Adult patients 18 years old and older
3 Patients with stage lll periodontitis having one isolated intrabony defect with probing depth 6 mm clinical attachment level 6 mm and at least 4 mm intrabony component involving predominantly the interproximal area of the affected tooth
4 Patients with full mouth plaque score20
5 Patients with full mouth bleeding score20
6 Compliance with good oral hygiene
7 Patients accept 6-months follow-up period cooperative patients
8 Patients provide an informed consent
II Exclusion criteria
1 Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis
2 One wall intrabony defect
3 Defects that involve the buccal and lingual sites
4 Smokers 10 cigarettes day
5 Pregnant and lactating females
General operative procedures
1Preoperative preparation
Clinical examination
Each patient will be examined to confirm that heshe met the eligibility criteria This is followed by
1 Full mouth charting to evaluate the periodontal status will be performed by using UNC 15 periodontal probe including assessment of plaque index PI bleeding on probing BOP probing depth PD clinical attachment level CAL gingival recession and radiographic x-ray imaging
2 Patients will be thoroughly informed on self-performed plaque control activities consisting of using the modified Bass brushing technique a soft toothbrush regular toothpaste twice a day and inter-dental cleaning once a day
3 The patients will receive supra gingival scaling with ultrasonic scaler then they will be recalled after 2 weeks 4_An oral hygiene session will be performed two weeks before the surgical treatments
Each patient will be prescribed a 02 chlorhexidine-based mouthwash twice a day for two weeks Clinical photographs Clinical photographs will be taken at baseline and at 12 months postoperatively Radiographic examination Periapical radiographs using paralleling technique using KCP film holder will be performed for each patient on the defect site to evaluate alveolar bone loss using DIGORA system
Initial Therapy
The initial therapy will consist of periodontal treatment phase I therapy including supra gingival scaling subgingival debridement if needed adjustment of faulty restoration and polishing The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques
Re-evaluation phase
4-6 weeks after the initial therapy periodontal re-evaluation will be done to confirm the sites that will require surgical therapy
Criteria used to indicate that surgery is required include the persistence of interproximal defect with PD 5 mm CAL 4 mm
An individually customized positioning stent will be fabricated for each patient and a pre-operative periapical x-ray using parallel-angle technique will be employed using X-ray film holding system to ensure accuracy and reproducibility of the measurements
Surgical procedures
Pre-procedural mouth rinse using 02 chlorhexidine gluconate3 rinses for intraoral antisepsis
Surgical sites will be anaesthetized using local anesthesia
Following a buccal intra-crevicular incision a bevelled vertical releasing incision will be performed in the buccal gingiva of the neighbouring inter-dental space and extended just beyond the mucogingival line The Entire papilla preservation technique_EPPTto provide adequate mechanical access to the intra-bony defect A microsurgical periosteal elevator will be used to elevate a buccal full-thickness mucoperiosteal flap extending from the vertical incision to the defect-associated papilla
The inter-dental papilla will be elevated in full-thickness manner up to the intact lingual bone crest
A microsurgical scissor and mini curettes will be used to remove the granulation tissue from the inner aspect of the defect-associated inter-dental papilla
Any residual subgingival plaque or calculus will be gently removed from the exposed root surface with an ultrasonic scaler
The surgical site will be thoroughly rinsed with sterile saline
The participants will be divided into two groups
Intervention group
The Entire papilla preservation surgical technique EPPT will be performed to approach the intra-bony defects with autogenous bone graft mixed with injectable platelet rich fibrin I-PRF placement The graft will be harvested from the retromolar area using automatic chip maker ACM bur and a hand bone mill will be used to grind the chips into particles then it will be mixed with I-PRF and placed in the defect
I-PRF will be prepared as followsChoukroun et al 2018 10 ml of peripheral venous blood will be collected into a sterile 10 ml plastic PRF tube to reduce clotting time without anticoagulants and centrifuged immediately at room temperature using centrifugal force 700 rpm for 3 minutes 60gRCF then the yellow fluid liquid fibrinogen at the top of the tubes will be aspirated with a blunt sterile syringe avoiding red blood cells
Control group
The Entire papilla preservation surgical technique EPPT will be performed to approach the intra-bony defects without autogenous bone graft and Injectable platelet rich fibrin placement
For both groups flaps will be approximated and sutured at the original position with a 5-0 or 6_0 monofilament polypropylene suture material Postoperative Care
Participants will be given instructions to avoid any trauma to the surgical site refrain from interfering with the sutures and to avoid consuming hot food or engaging in vigorous rinsing
They will be advised to continue tooth brushing for the other parts of their dentition while gentle tooth brushing for the surgical site will be advised to be resumed after a two-week period
The patients will be requested to rinse gently with 012 chlorhexidine digluconate mouth rinse for 1 minute twice daily for a duration of two weeks
Participants will be prescribed either Amoxicillin 500 mg Misr Co for Pharmaceutical Industries Egypt three times daily for five days or doxycycline 100mg Doxycycline Nile Co for Pharmaceuticals and Chemical Industries Egypt twice daily if they have allergy to penicillin
Sutures will be removed two weeks after the surgery
All the subjects will be evaluated at 1 3 6 and 12 months for clinical and radiographic parameters OutcomesThe results of Clinical attachmentlevel CAL gain Linear bone fill Gingival index GI Plaque index PI Probing pocket depth PPD Gingival recession GR Bleeding on probing BoP Postoperative pain and Patient satisfaction will be measured at baseline 1 month 3 months 6 months and after 12 months
Research Procedure in brief
The study is to be conducted in the Oral Medicine and Periodontology department Faculty of Dentistry - Cairo University Egypt This study will be carried out on patients enrolled from the Outpatient Clinic of Oral Medicine and Periodontology department Faculty of Dentistry Cairo University
Eligibility criteria
I Inclusion criteria
1 Patients with healthy systemic condition
2 Adult patients 18 years old and older
3 Patients with stage lll periodontitis having one isolated intrabony defect with probing depth 6 mm clinical attachment level 6 mm and at least 4 mm intrabony component involving predominantly the interproximal area of the affected tooth
4 Patients with full mouth plaque score20
5 Patients with full mouth bleeding score20
6 Compliance with good oral hygiene
7 Patients accept 6-months follow-up period cooperative patients
8 Patients provide an informed consent
II Exclusion criteria
1 Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis
2 One wall intrabony defect
3 Defects that involve the buccal and lingual sites
4 Smokers 10 cigarettes day
5 Pregnant and lactating females
General operative procedures
1Preoperative preparation
Clinical examination
Each patient will be examined to confirm that heshe met the eligibility criteria This is followed by
1 Full mouth charting to evaluate the periodontal status will be performed by using UNC 15 periodontal probe including assessment of plaque index PI bleeding on probing BOP probing depth PD clinical attachment level CAL gingival recession and radiographic x-ray imaging
2 Patients will be thoroughly informed on self-performed plaque control activities consisting of using the modified Bass brushing technique a soft toothbrush regular toothpaste twice a day and inter-dental cleaning once a day
3 The patients will receive supra gingival scaling with ultrasonic scaler then they will be recalled after 2 weeks 4_An oral hygiene session will be performed two weeks before the surgical treatments
Each patient will be prescribed a 02 chlorhexidine-based mouthwash twice a day for two weeks Clinical photographs Clinical photographs will be taken at baseline and at 12 months postoperatively Radiographic examination Periapical radiographs using paralleling technique using KCP film holder will be performed for each patient on the defect site to evaluate alveolar bone loss using DIGORA system
Initial Therapy
The initial therapy will consist of periodontal treatment phase I therapy including supra gingival scaling subgingival debridement if needed adjustment of faulty restoration and polishing The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques
Re-evaluation phase
4-6 weeks after the initial therapy periodontal re-evaluation will be done to confirm the sites that will require surgical therapy
Criteria used to indicate that surgery is required include the persistence of interproximal defect with PD 5 mm CAL 4 mm
An individually customized positioning stent will be fabricated for each patient and a pre-operative periapical x-ray using parallel-angle technique will be employed using X-ray film holding system to ensure accuracy and reproducibility of the measurements
Surgical procedures
Pre-procedural mouth rinse using 02 chlorhexidine gluconate3 rinses for intraoral antisepsis
Surgical sites will be anaesthetized using local anesthesia
Following a buccal intra-crevicular incision a bevelled vertical releasing incision will be performed in the buccal gingiva of the neighbouring inter-dental space and extended just beyond the mucogingival line The Entire papilla preservation technique_EPPTto provide adequate mechanical access to the intra-bony defect A microsurgical periosteal elevator will be used to elevate a buccal full-thickness mucoperiosteal flap extending from the vertical incision to the defect-associated papilla
The inter-dental papilla will be elevated in full-thickness manner up to the intact lingual bone crest
A microsurgical scissor and mini curettes will be used to remove the granulation tissue from the inner aspect of the defect-associated inter-dental papilla
Any residual subgingival plaque or calculus will be gently removed from the exposed root surface with an ultrasonic scaler
The surgical site will be thoroughly rinsed with sterile saline
The participants will be divided into two groups
Intervention group
The Entire papilla preservation surgical technique EPPT will be performed to approach the intra-bony defects with autogenous bone graft mixed with injectable platelet rich fibrin I-PRF placement The graft will be harvested from the retromolar area using automatic chip maker ACM bur and a hand bone mill will be used to grind the chips into particles then it will be mixed with I-PRF and placed in the defect
I-PRF will be prepared as followsChoukroun et al 2018 10 ml of peripheral venous blood will be collected into a sterile 10 ml plastic PRF tube to reduce clotting time without anticoagulants and centrifuged immediately at room temperature using centrifugal force 700 rpm for 3 minutes 60gRCF then the yellow fluid liquid fibrinogen at the top of the tubes will be aspirated with a blunt sterile syringe avoiding red blood cells
Control group
The Entire papilla preservation surgical technique EPPT will be performed to approach the intra-bony defects without autogenous bone graft and Injectable platelet rich fibrin placement
For both groups flaps will be approximated and sutured at the original position with a 5-0 or 6_0 monofilament polypropylene suture material Postoperative Care
Participants will be given instructions to avoid any trauma to the surgical site refrain from interfering with the sutures and to avoid consuming hot food or engaging in vigorous rinsing
They will be advised to continue tooth brushing for the other parts of their dentition while gentle tooth brushing for the surgical site will be advised to be resumed after a two-week period
The patients will be requested to rinse gently with 012 chlorhexidine digluconate mouth rinse for 1 minute twice daily for a duration of two weeks
Participants will be prescribed either Amoxicillin 500 mg Misr Co for Pharmaceutical Industries Egypt three times daily for five days or doxycycline 100mg Doxycycline Nile Co for Pharmaceuticals and Chemical Industries Egypt twice daily if they have allergy to penicillin
Sutures will be removed two weeks after the surgery
All the subjects will be evaluated at 1 3 6 and 12 months for clinical and radiographic parameters OutcomesThe results of Clinical attachmentlevel CAL gain Linear bone fill Gingival index GI Plaque index PI Probing pocket depth PPD Gingival recession GR Bleeding on probing BoP Postoperative pain and Patient satisfaction will be measured at baseline 1 month 3 months 6 months and after 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None