Alveolar Socket Healing With and Without PRGF

NCT04383158 | Completed

• 1 other identifier: IRAS 279109
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

A single-centre randomised controlled pilot study involving 12-24 healthy adult patients for investigating dental extraction socket healing with and without plasma rich in growth factors (PRGF) taking place during early days of healing (days 1, 3, 7, 15, 30) and relating the healing to clinical and histological outcomes after 90 days of healing. Healing will be investigated by means of various non-invasive imaging technologies (e.g. laser scanners, thermal cameras, laser cameras) in addition to conventional technologies (e.g. bone core biopsy, 3D xray images). At 90 days of healing, dental implants will be placed in the healed sockets and implants will be restored and followed up until 12 months after connecting the prosthesis to the implant (e.g. implant crown). Dental implant outcomes (e.g. survival, success) will also be evaluated.

Conditions

Alveolar Bone Resorption; Wound Heal

Keywords

alveolar ridge preservation; autologous platelet concentrates; 3-D; randomised controlled study; plasma rich in growth factors; PRGF; Dental Implants

Outcome Measures

Primary Outcomes (1)

• Intra-oral geometric and thermographic changes of the alveolar ridge

  Changes expressed as percentages of intra-oral geometric volumes and temperatures within a defined region of interest (ROI) at 1, 3, 7, 15, 30 and 90 days after dental extraction in unassisted socket healing and PRGF-assisted healing. The ROIs will include the buccal, crestal, and palatal surfaces of the extraction socket defined proximally between two vertical planes parallel to the tooth axis in the middle of the mesial and distal papilla, and defined superiorly by a horizontal plane at the level of the mucogingival line.dental extraction in unassisted socket healing and PRGF-assisted healing.

  From dental extraction and post-operative days 1, 3, 7, 15, 30 and 90.

Secondary Outcomes (14)

• Extra-oral geometric changes of the whole face at 1, 3, 7, 15, and 30 days after dental extraction

  From dental extraction and post-operative days 1, 3, 7, 15, and 30.

• Extra-oral thermographic changes of the whole face at 1, 3, 7, 15, 30 and 90 days after dental extraction

  From dental extraction and post-operative days 1, 3, 7, 15, 30 and 90.

• Blood flowgraphy changes of intra-oral soft tissue of the dental extraction socket

  From dental extraction and post-operative days 1, 3, 7, 15, 30 and 90.

• Molecular (proteomic) changes of wound exudate of the dental extraction socket

  From dental extraction and post-operative days 1, 3, 7, and 15.

• Clinical changes of the intra-oral soft tissue of the dental extraction socket measured by soft tissue healing index of Landry (Landry, 1985)

  From dental extraction and post-operative days 1, 3, 7, and 15.

Study Arms (2)

PRGF extraction sockets (Test)

ACTIVE COMPARATOR

Immediately after dental extraction, the socket will be filled with Plasma Rich in Growth Factors (ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16))

Other: PRGF ENDORET® obtained from ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16)

Unassisted extraction sockets (Control)

NO INTERVENTION

Dental extraction sockets to be left to heal spontaneously unassisted.

Interventions

PRGF ENDORET® obtained from ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16) OTHER

ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16) is a system for obtaining plasma rich in growth factors (PRGF), which can be applied in the regeneration of bone and other connective tissues in oral surgery. PRGF is a completely autologous blood platelet concentrate that stimulates tissue regeneration due to enrichment with autologous growth factors, acting as a biological system.

PRGF extraction sockets (Test)

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have willingness to read and sign a copy of the Informed Consent Form Males and females, ≥25 years old.
• Patient in need of a single permanent tooth extraction with clinical and/or radiographic evidence of unrestorable maxillary premolars, canines, or incisors with at least one adjacent tooth present, and with periodontal attachment preserved at least for 2/3rd of the root nor associated with acute periapical pathology.
• Post-extraction alveolar bone defect with ≤50 % buccal bone loss. This will be confirmed at Visit 2 after extraction. In case of \>50% buccal bone loss, the participant will be withdrawn.
• Patient in good general health as documented by self-assessment.
• Full mouth bleeding and plaque scores (FMBS \<10% and FMPS \<20%) recorded within the previous 8 weeks.

You may not qualify if:

• Uncontrolled or untreated periodontal disease.
• History of local (head and neck) radiation therapy.
• Presence of oral lesions in the area of the extraction (such as ulceration, malignancy).
• Severe bruxing or clenching habits.
• Acute endodontic lesion in the test tooth or in the neighbouring areas to the extraction procedure (sites with presence of an asymptomatic chronic lesion are eligible).
• Medical history that includes uncontrolled diabetes or hepatic or renal disease, or other serious medical conditions that can impact on bone metabolism (e.g. rheumatoid arthritis, osteoporosis) or transmittable diseases (e.g. AIDS).
• History of alcohol or drug abuse.
• Smokers.
• Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
• Malocclusion, or collapse of the occlusal vertical dimension leading to dentoalveolar compensation which could interfere with ridge preservation dimensions and measurements.
• Lack of adjacent sound restored or unrestored teeth.
• Any male participants with facial hair (such as moustache, beard or any other variations of facial hair styles) and must keep their face shaven until after the placement of the dental implant (Visit 10).
• Any individuals using Botox or fillers in the face region.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Centre for Oral Clinical Research

London, E1 2AD, United Kingdom

Location

Study Officials

• Nikolaos Donos, DDS, MS, PhD

  Centre for Oral Clinical Research, Institute of Dentistry, Barts & The London School of Medicine & Dentistry, QMUL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, controlled, single-centre, prospective, parallel-group qualitative pilot study

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 12, 2020
• Study Start: August 10, 2021
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

GB (1)