Placenta Extract Gel as a Periodontal Local Delivery Drug

NCT ID: NCT06506539

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-03-01

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

Conditions

Periodontal Pocket; Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

scaling and root planning only

Group Type: NO_INTERVENTION

No interventions assigned to this group

scaling and root planning+planenta extract gel group

Group Type: ACTIVE_COMPARATOR

Placental Extract

Intervention Type: DRUG

add placental extract gel as a local delivery drug in periodontal pocket

Interventions

Placental Extract

add placental extract gel as a local delivery drug in periodontal pocket

Intervention Type: DRUG

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Aya mohamed ahmed awad

dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

dalia fayad, Phd

Role: PRINCIPAL_INVESTIGATOR

Suez Canal University

Locations

Suez Canal University

Ismailia, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 14121956 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14158464 (View on PubMed)

Other Identifiers

336/2021

Identifier Type: -

Identifier Source: org_study_id