Guided Bone Regeneration in Alveolar Socket

NCT05577663 | Recruiting DMC

• 1 other identifier: AUTh-79/13-02-2020
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Following tooth extraction, volumetric changes in the soft and hard tissues of the extraction site are expected to occur with considerable resorption of the alveolar bone in both the vertical and the horizontal dimensions. These changes may complicate surgical implant placement and may also compromise the outcome of the prosthetic reconstruction. Various treatment approaches have been introduced aiming to preserve the dimensions of the alveolar ridge at the extraction site and facilitate optimal implant placement. This prospective randomized controlled trial aims to determine the efficacy of alveolar ridge preservation utilizing two different socket seal approaches compared to spontaneous healing to stabilize the blood clot within the postextraction socket. Thirty-six subjects will be randomly allocated into one of the three treatment groups. Group-A: Extraction of the tooth and suturing of the extraction socket with resorbable suture PGA 5/0. Group-B: Extraction of the tooth and placement of a Free Gingival Graft stabilized with resorbable suture PGA 5/0. Group-C: Extraction of the tooth and placement of the Polylactic-Glycolic Acid membrane stabilized with resorbable suture PGA 5/0. After the initial examination for screening, subjects will be assessed at baseline-extraction day- and after 1, 2, and 6 weeks, and 3 months. The changes of the alveolar crest will be determined in height and width, in addition to volumetric changes in the soft tissues, and the width of keratinized tissues. The wound healing process will be visually assessed.

Conditions

Alveolar Bone Resorption

Keywords

socket seal; randomized controlled clinical trial; alveolar ridge preservation; polylactic-glycolic acid membrane; free gingival graft; spontaneous healing

Outcome Measures

Primary Outcomes (2)

• Osseous changes in height of the alveolar ridge

  The height of the alveolar ridge will be measured at standardized points distal, mesial and buccal/ palatal/ lingual at standardized points with the use of a reference stent by a CBCT.

  Clinically: immediately after tooth extraction(baseline), 6 weeks and 3 months after the extraction. CBCT: immediately after the extraction and 3 months after the extraction

• Osseous changes in width of the alveolar ridge

  The width of the alveolar ridge will be measured distal, mesial and buccal/ palatal/ lingual at standardized points with the use of a reference stent by a CBCT.

  Immediately after the extraction(baseline) and 3 months after the extraction

Secondary Outcomes (3)

• Mucosa thickness changes

  Baseline, 6 weeks and 3 months after the extraction

• Width of keratinized tissues

  Baseline, 6 weeks and 3 months after the extraction

• Wound healing

  1 and 2 weeks after the extraction

Study Arms (3)

Spontaneous healing

OTHER

Routine treatment of the extraction socket. Extraction of the tooth and suturing of the extraction socket with resorbable suture PGA 5/0 (polygalactic acid 5/0 sutures; PGA, medipac, Greece).

Other: Routine treatment of the extraction socket

Free gingival graft

ACTIVE COMPARATOR

Extraction of the tooth, placement of a Free Gingival Graft taken from the palate and adjusted to seal the socket opening and stabilize it by resorbable sutures PGA 5/0 (polygalactic acid 5/0 sutures; PGA, medipac, Greece).

Procedure: Socket seal technique by a free gingival graft

Polylactic-Glycolic Acid membrane

EXPERIMENTAL

Extraction of the tooth, adjustment of the Polylactic-Glycolic Acid membrane (PLGA,Tisseos®, Biomedical Tissues, Septodont, France) over the socket opening resting by 1 mm over the alveolar crest of the extraction socket. Tissues are sutured over the barrier by resorbable sutures PGA 5/0 (polygalactic acid 5/0 sutures; PGA, medipac, Greece).

Procedure: Socket seal technique using a synthetic resorbable membrane

Interventions

Routine treatment of the extraction socket OTHER

Suturing of the extraction socket with resorbable suture PGA 5/0 in order to protect the blood clot

Spontaneous healing

Socket seal technique by a free gingival graft PROCEDURE

Placement of a free gingival graft in the socket opening in order to protect and stabilize the blood clot followed by suturing

Free gingival graft

Socket seal technique using a synthetic resorbable membrane PROCEDURE

Placement of a synthetic barrier in the socket opening in order to protect and stabilize the blood clot followed by suturing

Polylactic-Glycolic Acid membrane

Eligibility Criteria

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

You may qualify if:

• Referrals for a single tooth extraction
• Periodontal destruction less than 50% of tooth support
• Signed inform consent form

You may not qualify if:

• Systematic diseases, contradicting surgical procedures and compromise wound healing (i.e. uncontrolled diabetes)
• Medication that interferes with bone metabolism
• Pregnancy or lactation
• Multiple extractions
• Absence of adjacent teeth
• Loss of buccal bone, either due to periodontal disease or because of traumatic extraction

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• University Paul Sabatier of Toulouse: collaborator

Study Sites (1)

Dental School, Aristotle University, Dept of Preventive Dentistry, Periodontology and Implant Biology

Thessaloniki, 54124, Greece

RECRUITING

Related Publications (6)

• Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.

  PMID: 15691354 BACKGROUND

• Farmer M, Darby I. Ridge dimensional changes following single-tooth extraction in the aesthetic zone. Clin Oral Implants Res. 2014 Feb;25(2):272-7. doi: 10.1111/clr.12108. Epub 2013 Jan 25.

  PMID: 23346895 BACKGROUND

• Maiorana C, Poli PP, Deflorian M, Testori T, Mandelli F, Nagursky H, Vinci R. Alveolar socket preservation with demineralised bovine bone mineral and a collagen matrix. J Periodontal Implant Sci. 2017 Aug;47(4):194-210. doi: 10.5051/jpis.2017.47.4.194. Epub 2017 Aug 11.

  PMID: 28861284 BACKGROUND

• Prato GP, Cairo F, Tinti C, Cortellini P, Muzzi L, Mancini EA. Prevention of alveolar ridge deformities and reconstruction of lost anatomy: a review of surgical approaches. Int J Periodontics Restorative Dent. 2004 Oct;24(5):434-45. doi: 10.11607/prd.00.0602.

  PMID: 15506024 BACKGROUND

• Jung RE, Siegenthaler DW, Hammerle CH. Postextraction tissue management: a soft tissue punch technique. Int J Periodontics Restorative Dent. 2004 Dec;24(6):545-53.

  PMID: 15626317 BACKGROUND

• Annunziata M, Guida L, Nastri L, Piccirillo A, Sommese L, Napoli C. The Role of Autologous Platelet Concentrates in Alveolar Socket Preservation: A Systematic Review. Transfus Med Hemother. 2018 May;45(3):195-203. doi: 10.1159/000488061. Epub 2018 May 3.

  PMID: 29928175 BACKGROUND

MeSH Terms

Conditions

Remission, Spontaneous

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Danae Apatzidou, Assoc. Professor

CONTACT

+306934770361; dapatzidou@dent.auth.gr

Marilena Kalliopi Louvrou, PG student

CONTACT

+306979360874; marilenal1994@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment is disclosed to the examiner after all data have been collected; investigator and care provider are different individuals.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomised controlled clinical trial having 3 parallel intervention arms for alveolar ridge preservation and prevention of future alveolar bone resorption due to volumetric changes of tissues post-tooth extraction.

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: October 1, 2022
• Primary Completion: March 30, 2024
• Study Completion: December 1, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)