Human Placenta Extract Use in Socket Preservation

NCT06915675 | Active Not Recruiting DMC

• 1 other identifier: USJ-2024-175
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This split-mouth pilot study evaluates the effectiveness of flowable decellularized Human Placental Connective Tissue Matrix (HPCTM) in alveolar ridge preservation following tooth extraction. Patients will receive HPCTM mixed with allograft particles in one extraction socket and allograft particles solely in the contralateral socket. The primary outcome is to assess dimensional changes in the alveolar ridge in terms of soft tissue shrinkage using a super-imposed intra-oral scans taken at baseline , day 10, 21 and 30 post-op and bone resorption rate by comparing pre-op and 4 months post-op cone beam computed tomography scans. Secondary outcomes include clinical soft tissue healing evaluation and commentary. The HPCTM used in this study is regulated by the US FDA under Section 361 of the Public Health Service Act (21 CFR Part 1271.10(a)).

Conditions

Dental Extraction

Keywords

Alveolar ridge; Connective tissue; Extracellular matrix; Placental extracts; Wound healing; Tooth extraction

Outcome Measures

Primary Outcomes (2)

• Soft tisse shrinakge at different time points of the test and control groups

  Using a measurement software ( Medit design, Medit, Republic of Korea) the intra-oral scans (.STL files) obtained at different time points of the healing process will be super-imposed and aligned. the following region of interest will be selected: * Mesio-distally: 1,5 mm away from the concerned papilla peak. * Apically: A bucco-lingual/palatal line tangent to the visible muco-gingival line and parallel to the occlusal surface. The deviation between the different scans which corresponds the soft tissue shrinkage will be automatically calculated in millimeters as a mean value with standard deviation

  30 days

• Bone resorption rate in test and control groups

  . A semi-automatic segmentation software (ITK-Snap 4.0, U.S. National Institute of Biomedical Imaging and BioEngineering, USA) was used to load and segment the pre and post CBCT scans. First, both CBCTs were oriented according to the Frankfort plane, then aligned using multiple fixe landmarks in different orientations to ensure a perfect match and an easy reproducibility. A standard region of interest was applied for all the measured sites as follow: A standard region of interest was applied for all the measured sites as follow: * Mesio-distal limit: 1.5 mm away from the mesial and distal surface of adjacent tooth. * Bucco-lingual limit: limited to the observed bone dimensions. * Apico-coronal limit: Coronally the most detectable bone peak at the mesial and distal sides; apically, 1.5 mm below the root tip. Using pixel-based scale, a specific threshold value was used to select and separate the desired structure from its surroundings of both pre and post-surgery CBCT. Following the aut

  4 months

Secondary Outcomes (1)

• Clinical observation of the wound healing at control and test groups at 10, 21 and 30 days post-op

  30 days

Study Arms (2)

Placenta treatment arm

ACTIVE COMPARATOR

Participants will receive allografts bone substitutes mixed with flowable human placental based connective tissue matrix in one extraction socket immediately following tooth extraction.

Biological: Placental Extract

Control arm

SHAM COMPARATOR

Participants will receive allografts bone substitutes solely in one extraction socket immediately following tooth extraction.

Procedure: Allograft

Interventions

Placental Extract BIOLOGICAL

Participants will receive allografts bone substitutes mixed with flowable human placental derived connective tissue matrix in one extraction socket immediately following tooth extraction.

Placenta treatment arm

Allograft PROCEDURE

Participants will receive allografts bone substitutes solely in one extraction socket immediately following tooth extraction.

Control arm

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ranging between 20 and 60.
• Subjects having two hopeless teeth that needs extraction.
• Teeth fitting in the same morphological category (mono,bi or multirooted).
• Teeth belonging to different arch quadrants.
• Presence of more than half of the socket bone housing.
• Non-smoking patient.

You may not qualify if:

• Presence of active periodontal diseases i.e Miller class II and above categories.
• Presence of heavy metallic artefacts that can distort CBCT scans.
• Bad oral hygiene and non-compliance.
• Systemic diseases interfering with bone metabolism.
• Pregnant or lactating women.

Sponsors & Collaborators

• Saint-Joseph University: lead
• Botiss Biomaterials GmbH: collaborator

Study Sites (1)

Saint Joseph University of Beirut

Beirut, Beyrouth, 1101, Lebanon

Location

Related Publications (4)

• Gulameabasse S, Gindraux F, Catros S, Fricain JC, Fenelon M. Chorion and amnion/chorion membranes in oral and periodontal surgery: A systematic review. J Biomed Mater Res B Appl Biomater. 2021 Aug;109(8):1216-1229. doi: 10.1002/jbm.b.34783. Epub 2020 Dec 22.

  PMID: 33354857 BACKGROUND

• Kalsi AS, Kalsi JS, Bassi S. Alveolar ridge preservation: why, when and how. Br Dent J. 2019 Aug;227(4):264-274. doi: 10.1038/s41415-019-0647-2.

  PMID: 31444438 BACKGROUND

• Chappuis V, Araujo MG, Buser D. Clinical relevance of dimensional bone and soft tissue alterations post-extraction in esthetic sites. Periodontol 2000. 2017 Feb;73(1):73-83. doi: 10.1111/prd.12167.

  PMID: 28000281 BACKGROUND

• Chappuis V, Engel O, Reyes M, Shahim K, Nolte LP, Buser D. Ridge alterations post-extraction in the esthetic zone: a 3D analysis with CBCT. J Dent Res. 2013 Dec;92(12 Suppl):195S-201S. doi: 10.1177/0022034513506713. Epub 2013 Oct 24.

  PMID: 24158340 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Placental Extracts; Transplantation, Homologous

Intervention Hierarchy (Ancestors)

Tissue Extracts; Complex Mixtures; Transplantation; Surgical Procedures, Operative

Study Officials

• Ronald Joseph Younes, DDS,MSc, Phd

  Saint Joseph University of Beirut

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Following the inclusion and exclusion criteria, 10 patients presenting a split mouth design will be enrolled in the study where one dental extraction site will serve as a test and the other will be the control

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 8, 2025
• Study Start: August 23, 2024
• Primary Completion: February 11, 2025
• Study Completion: April 10, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)