Placenta Extract Gel as a Periodontal Local Delivery Drug

NCT06506539 | Completed Phase 2 DMC

• 1 other identifier: 336/2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Pocket; Periodontitis

Keywords

placenta extract gel; periodontitis; local delivery drug

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Vascular endothelial growth factor (VEGF)

  3 months

• fibroblast growth factor (FGF)

  3 months

Study Arms (2)

scaling and root planning only

NO INTERVENTION

scaling and root planning+planenta extract gel group

ACTIVE COMPARATOR

Drug: Placental Extract

Interventions

Placental Extract DRUG

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

scaling and root planning+planenta extract gel group

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, Egypt

Location

Related Publications (2)

• 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.

  PMID: 14121956 BACKGROUND

• 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.

  PMID: 14158464 BACKGROUND

MeSH Terms

Conditions

Periodontal Pocket; Periodontitis

Interventions

Placental Extracts

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Tissue Extracts; Complex Mixtures

Study Officials

• dalia fayad, Phd

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 17, 2024
• Study Start: April 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: March 1, 2022
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)