Clinical trial
Erythropoietin Gel as an Adjunct to Xenograft in the Surgical Management of Intrabony Periodontal Defects. A Randomized Controlled Clinical Study
Name
EPO In periodontitis
Description
The aim of the study is to evaluate the use of erythropoietin gel as an adjunct to xenograft in the surgical management of intrabony periodontal defects.
Trial arms
Trial start
2022-07-01
Estimated PCD
2023-09-01
Trial end
2023-10-01
Status
Completed
Phase
Early phase I
Treatment
particulate xenograft + erythropoietin gel.
1. Surgical sites will be anaesthetized using local anaesthesia.
2. Intrasulcular incision will be done in the periodontal pocket as close as possible to the tooth surface with the deepest point being the alveolar crest.
3. The incisions will be extended to the mesial papilla of the tooth before the defect and the distal papilla of the tooth after the defect.
4. Both buccal and lingual/palatal mucoperiosteal flaps will be raised using blunt dissection.
5. Mechanical debridement of the infected tissue from the intrabony defect and root debridement will be done using Gracey curettes.
* In Group A (test group):
Particulate xenograft will be mixed with EPO gel and applied to fill the whole defect.
Arms:
Group A (Test group)
Other names:
The mix of xenograft and EPO gel
particulate xenograft
* All surgeries will be performed by the same operator as follows:
1. Surgical sites will be anaesthetized using local anaesthesia.
2. Intrasulcular incision will be done in the periodontal pocket as close as possible to the tooth surface with the deepest point being the alveolar crest.
3. The incisions will be extended to the mesial papilla of the tooth before the defect and the distal papilla of the tooth after the defect.
4. Both buccal and lingual/palatal mucoperiosteal flaps will be raised using blunt dissection.
5. Mechanical debridement of the infected tissue from the intrabony defect and root debridement will be done using Gracey curettes.
* In Group B (control group):
Particulate xenograft will be applied to fill the whole defect.
Arms:
Group B (Control group)
Other names:
The xenograft alone
Size
26
Primary endpoint
Evaluation of Plaque index (PI):
at baseline (before the surgery by one week)
Evaluation of Plaque index (PI):
6 months after the surgery.
Evaluation of the Sulcus bleeding index (SBI):
at baseline (before the surgery by one week)
Evaluation of the Sulcus bleeding index (SBI):
6 months after the surgery.
Evaluation of the probing depth :
at baseline (before the surgery by one week)
Evaluation of the probing depth :
6 months after the surgery.
Evaluation of the clinical attachment level :
at baseline (before the surgery by one week)
Evaluation of the clinical attachment level :
6 months after the surgery.
Evaluation of healing.
one week after the surgery.
Evaluation of healing.
two weeks after the surgery.
Eligibility criteria
Inclusion Criteria:
1. Both genders within age range of 20-50 years.
2. Patients diagnosed with periodontitis (Stage III).
3. Test site criteria: probing pocket depth ≥6mm and CAL ≥3mm. All these criteria will be determined after phase I conventional periodontal therapy.
4. Patients with three-wall intrabony defect.
5. Systemically free patients as evidenced by Burket's oral health history questionnaire .
6. Ability to attend the treatment sessions and comply with its procedures, the recall visits and oral hygiene protocol.
* Exclusion Criteria:
1. Smokers.
2. Pregnant or lactating females.
3. Patients under any medication that affect periodontal healing.
4. Vulnerable individuals
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 26, 'type': 'ACTUAL'}}
Updated at
2024-01-16
1 organization
2 products
1 indication
Organization
Ain Shams UniversityIndication
Periodontal Bone LossProduct
Particulate Xenograft