Placenta Extract Gel as a Periodontal Local Delivery Drug

Clinical and Laboratory Evaluation of Placenta Extract Gel as an Adjunct to Non Surgical Periodontal Therapy in Patients With Grade B Stage II Periodontitis

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Periodontal Pocket
• Intervention / Treatment: Drug: Placental Extract

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt
    • Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: scaling and root planning only
Active Comparator: scaling and root planning+planenta extract gel group	Drug: Placental Extract; add placental extract gel as a local delivery drug in periodontal pocket

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plaque index (PI)	PI was used to determine the amount of plaque on the tooth surface To determine the plaque index, Silness & Löe reference values were taken as a basis: Plaque index 0: No plaque is in the area adjacent to the gingiva. Plaque index 1: There is a plaque in the form of a thin film on the gingival margin. Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin. Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin.	3 months
gingival index (GI)	o determine the gingival index of the patients, gingival bleeding caused by running a Williams periodontal probe inside the pocket on the mesial, distal, buccal, and palatal surfaces of all teeth was evaluated. The gingival index of an individual was obtained by summing the values determined for each tooth and calculating the averages. To determine the gingival index, Löe & Silness reference values were taken as a basis: Gingival index 0: Healthy gums. Gingival index 1: Mild discolouration and oedematous gingiva. No bleeding on probing. Gingival index 2: Red, oedematous and shiny gingiva. There is bleeding on probing. Gingival index 3: Red, oedematous, and ulcerated gingiva. There is spontaneous bleeding.	3 months
probing pocket depth (PD)	Measured from the free gingival margin to the bottom of the pocket with an unc 15 periodontal probe	3 months
clinical attachment level(CAL).	The distance from CEJ to the bottom of the pocket. It was measured in the same way described for probing depth. CAL was recorded by subtracting the length of the deepest probing depth from the stent by the length from the stent to the cemento-enamel junction.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular endothelial growth factor (VEGF)	recorded in picograms per milliliter (pg/mL)	3 months
fibroblast growth factor (FGF)	recorded in picograms per milliliter (pg/mL)	3 months

Collaborators and Investigators

• Sponsor: Suez Canal University
• Investigators: Principal Investigator: dalia fayad, Phd, Faculty of Dentistry, Suez Canal University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: July 6, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: periodontitis; local delivery drug; placenta extract gel
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Periodontal Pocket
• Other Study ID Numbers: 336/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No