Clinical trial NCT06506539: Placenta Extract Gel as a Periodontal Local Delivery Drug
Official title: Clinical and Laboratory Evaluation of Placenta Extract Gel as an Adjunct to Non Surgical Periodontal Therapy in Patients With Grade B Stage II Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontal Pocket
Periodontitis
Keywords: placenta extract gel
periodontitis
local delivery drug
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Periodontal disease is one of the most prevalent global chronic disorders. Pathology affecting the structure surrounding teeth results in inflammation initiated by bacterial aggregation and alteration in their profile.

conventional periodontal therapeutics has focused on the control of etiologic agents, thereby promoting healing, repair of tissues delivery of therapeutic agents into the pocket act as drug reservoirs which could alter pathogenic flora and promote its repair and wound healing. Aim of the study: Evaluate the effect of locally delivered placenta extract gel as an adjunct to scaling and root planning in the treatment of periodontal pocket. Methodology: 30 patients with grade B stage II periodontitis will be selected from the Faculty of Dentistry Suez Canal University outpatient clinic and divided into 2 equal groups. Group I: will have scaling and root planning.

Group II: will have scaling and root planning with placenta extract gel locally delivered in the periodontal pocket. All clinical parameters (plaque index, gingival index, probing pocket depth, and clinical attachment) and lab investigations (vascular endothelial growth factor and fibroblast growth factor) will be measured at 0,1 and 3 months. All results will be tabulated and statistically analyzed using the SPSS program.

Detailed description: Group I: (control group): where subgingival scaling and root planning will be performed and the pocket will be allowed to heal with secondary intention. Group II (test group): where subgingival scaling and root planing, and 1ml of human placental extracts gel\* adsorbed in 30 beads of gelatin foam of 1sq. mm, will be placed into the pockets with the help of a probe to fill the sulcus to the deepest point \& coepak will be placed. patients will be recalled after seven 12 days to remove the coePak. A customized acrylic stent will be fabricated for each patient to provide a reproducible insertion axis for the periodontal probe. The stent will be grooved in an occlusal-apical direction for the above-mentioned purpose.

Lab assessment:

The area will be isolated with cotton rolls, gingival crevicular fluid will be collected using a paper point three times for each pocket, and samples will be stored at -80°.

Vascular endothelial growth factor and fibroblast growth factor will be measured for the two groups using the ELISA technique.

Clinical assessment:

The following parameters will be recorded for the two groups: plaque index, gingival index depth, probing pocket, and clinical attachment.(Silness and Löe, 1964, Löe and Silness, 1963) Measurements will be taken from the stent to the deepest probing depth to record. Probing pocket depth (PPD) while Relative Attachment level (RAL) will be recorded by subtracting the length of the deepest probing depth from the stent from the length from the stent to the cemento-enamel junction All the clinical parameters will be recorded on day 0,1 months and 3 months and all results will be tabulated and statistically analyzed

Eligibility criteria: Inclusion Criteria:

- having a pocket of 4-5 mm ( grade B stage II periodontitis).

Exclusion Criteria:

* patients with known systemic conditions like Diabetes mellitus, hypertension, atherosclerosis, and other conditions known to affect periodontal status adversely.
* patients suffering from stage III grade C periodontitis.
* pregnant and lactating women,
* known harmful habits like alcohol consumption, and tobacco.
* any form of periodontal therapy during the last six months \& antimicrobial therapy during the last 3 months.

Primary outcomes:
measure: plaque index (PI)
timeFrame: 3 months
measure: gingival index (GI)
timeFrame: 3 months
measure: probing pocket depth (PD)
timeFrame: 3 months
measure: clinical attachment level(CAL).
timeFrame: 3 months
Secondary outcomes:
measure: Vascular endothelial growth factor (VEGF)
timeFrame: 3 months
measure: fibroblast growth factor (FGF)
timeFrame: 3 months
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
affiliation: Suez Canal University
name: dalia fayad, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
citation: SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.