Periosteal Inhibition Technique for Ridge Preservation A Prospective Study

Ridge Deficency Clinical Trial

— PI  

Official title:

Periosteal Inhibition Technique for Ridge Preservation A Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03763617
• Other study ID #: PI2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2018
• Source: Clinique Dentaire et d'implantologie Dr.Vinh Nguyen
• Contact: Vinh Giap Nguyen, DDS, MSc
• Phone: 1 514 605 3435
• Email: email[@]drvinhnguyen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The efficacy of the Periosteal Inhibition technique for socket preservation is studies against a control group in which the extraction sockets are allowed to heal without a socket preservation procedure.

Description:

Socket preservation procedures have been shown to significantly reduce the loss of ridge dimension of an extraction socket. These procedures involve filling the empty socket with a bone graft material, which, serves as scaffold to limit horizontal and vertical ridge alterations. In order to contain the graft material, an occlusive barrier such as an autogenous soft tissue graft, resorbable or non-resorbable membrane, is often required. As yet, no one socket preservation technique has been proven superior to another, and none have proven totally effective in preserving ridge morphology. A net reduction of 1.5 mm in ridge width and 0.5 mm in ridge height is often observed after socket preservation procedures, which may necessitate additional hard or soft tissue augmentation to fully restore the ridge dimension.

In an animal histologic study in 2005, Araujo and Lindhe demonstrated that trauma and loss of periodontal ligament triggered an osteoclastic activity causing loss of bundle bone and modeling of the cortical bone plate. Osteoclasts are multi-nucleated cells that are responsible for bone resorption and are found on the outer layer of bone, beneath the periosteum. Osteoclasts are thought to be derived from pluripotent hematopoietic stem cells. When stimulated, these mononuclear precursors, the smallest of which is 9.5 microns in diameter, proliferate and attach to the bone surface to be resorbed, and only then fuse to form large mature multinucleated osteoclasts.

High-density polytetrafluoroethylene (d-ptfe) membranes have been used in socket preservation procedures as an occlusive barrier to contain the bone graft material.Polytetrafluoroethylene, a stable polymer and highly biocompatible, has a membrane porosity of less than 0.3 microns. It is impervious to bacteria and thus is recommended for a socket preservation technique, where a membrane is intentionally exposed.

In the present study, a high-density polytetrafluoroethylene (d-ptfe) membrane is placed between the periosteum and the buccal bone plate of an extraction socket where it will stay for a duration of 4 months, the time needed for the completion of bone forming within the socket. The goal of the non-resorbable d-ptfe membrane is to prevent the migration of precursor cells to the bone surface and thus their fusion to form osteoclast. The authors hypothesize that the passage of the precursor cells from the periosteum to the bone surface is inhibited by the small-diameter pores in the non-resorbable d-ptfe membrane. Osteolytic activity on the outer surface of the socket is thereby prevented as the precursor cells cannot form osteoclasts. The author coins the term "Periosteal Inhibition technique" for this socket preservation procedure.The study will compare dimension changes between extraction socket treated using the Periosteal Inhibition technique and those allowed to heal without a socket preservation procedure.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

Inclusion Criteria:

• At least 22 years of age

• Systemically healthy

• An extraction of one non-salvageable molar or premolar tooth is indicated. Adjacent teeth must be present to support the measuring template.

• Demonstrated ability to maintain goodoral hygiene

• Willingness and ability to commit to follow-up

• Able to understand study procedure and provide signed informed consent.

Exclusion Criteria:

• Extensive damaged buccal or lingual bone plate

• Extreme alveolar ridge atrophy

• Extensive vertical bone loss

• Active infection at the extraction site

• Uncontrolled periodontal disease.

• Recent febrile illness (within 6 months) that precludes or delays participation

• Severe renal or liver diseases

• History of radiotherapy of the head and neck region

• Chemotherapy for treatment of malignant tumors at the time of the study.

• Immuno-compromised patients

• Patients on IV bisphosphonates or on long term oral bisphosphonates for more than 3 years.

• Use of disallowed concomitant medications.

• Pregnancy or intending to conceive during the course of the Study.

Related Conditions & MeSH terms

• Ridge Deficency

Intervention

Device:
• d-ptfe membrane
Socket preservation using d-ptfe membrane to inhibit the formation of osteoclasts

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Clinique Dentaire et d'implantologie Dr.Vinh Nguyen	Goethe University

References & Publications (27)

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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. — View Citation

Chappuis V, Engel O, Shahim K, Reyes M, Katsaros C, Buser D. Soft Tissue Alterations in Esthetic Postextraction Sites: A 3-Dimensional Analysis. J Dent Res. 2015 Sep;94(9 Suppl):187S-93S. doi: 10.1177/0022034515592869. Epub 2015 Jun 30. — View Citation

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Hoffmann O, Bartee BK, Beaumont C, Kasaj A, Deli G, Zafiropoulos GG. Alveolar bone preservation in extraction sockets using non-resorbable dPTFE membranes: a retrospective non-randomized study. J Periodontol. 2008 Aug;79(8):1355-69. doi: 10.1902/jop.2008.070502 . — View Citation

Iasella JM, Greenwell H, Miller RL, Hill M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol. 2003 Jul;74(7):990-9. — View Citation

Iocca O, Farcomeni A, Pardiñas Lopez S, Talib HS. Alveolar ridge preservation after tooth extraction: a Bayesian Network meta-analysis of grafting materials efficacy on prevention of bone height and width reduction. J Clin Periodontol. 2017 Jan;44(1):104-114. doi: 10.1111/jcpe.12633. Epub 2016 Dec 5. — View Citation

Laurito D, Cugnetto R, Lollobrigida M, Guerra F, Vestri A, Gianno F, Bosco S, Lamazza L, De Biase A. Socket Preservation with d-PTFE Membrane: Histologic Analysis of the Newly Formed Matrix at Membrane Removal. Int J Periodontics Restorative Dent. 2016 Nov/Dec;36(6):877-883. doi: 10.11607/prd.2114. — View Citation

MacBeth N, Trullenque-Eriksson A, Donos N, Mardas N. Hard and soft tissue changes following alveolar ridge preservation: a systematic review. Clin Oral Implants Res. 2017 Aug;28(8):982-1004. doi: 10.1111/clr.12911. Epub 2016 Jul 26. Review. — View Citation

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Sanz M, Cecchinato D, Ferrus J, Pjetursson EB, Lang NP, Lindhe J. A prospective, randomized-controlled clinical trial to evaluate bone preservation using implants with different geometry placed into extraction sockets in the maxilla. Clin Oral Implants Res. 2010 Jan;21(1):13-21. doi: 10.1111/j.1600-0501.2009.01824.x. Epub 2009 Nov 18. — View Citation

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Walker CJ, Prihoda TJ, Mealey BL, Lasho DJ, Noujeim M, Huynh-Ba G. Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Mar;88(3):241-249. doi: 10.1902/jop.2016.160445. Epub 2016 Oct 27. — View Citation

Willenbacher M, Al-Nawas B, Berres M, Kämmerer PW, Schiegnitz E. The Effects of Alveolar Ridge Preservation: A Meta-Analysis. Clin Implant Dent Relat Res. 2016 Dec;18(6):1248-1268. doi: 10.1111/cid.12364. Epub 2015 Jul 1. Review. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications	To assess complication rate of the procedure.	1 month, 2 months, 3 months and 4 months
Primary	Ridge widths	Bucco-lingual ridge dimensions at the midline is measured at 3mm and 5mm apical to the gingival margin, at the time of extraction intra-op and 4 months post-extraction, using a acrylic template for repeatable measurements.	0 hour and 4 months
Primary	Change in Ridge widths on the buccal and lingual aspects	Buccal and lingual ridge dimension change at the midline is measured at 3mm and 5mm apical to the gingival margin, at the time of extraction and 4 months post-extraction, using a acrylic template for repeatable measurements.	0 hour and 4 months
Primary	Change in Ridge heights	Change in Ridge bone heights at messiah and distal interproximal, mid-buccal and mid-lingual aspects.	0 hour and 4 months
Secondary	Bone plate thickness	Marginal buccal and lingual bone plate thickness	0 hour
Secondary	Keratinized mucosa	Width of keratinized mucosa over the ridge	0 hour and 4 months