Alveolar Ridge Preservation Procedures

Alveolar Ridge Preservation Clinical Trial

Official title:

Clinical Evaluation Of Soft Tissue Closure In Alveolar Ridge Preservation Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05419778
• Other study ID #: 18-06428-FB
• Status: Completed
• Start date: February 8, 2019
• Est. completion date: January 11, 2021

Study information

• Verified date: May 2022
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Tooth loss is accompanied by different patterns of bone loss. Up to 50% loss of alveolar crestal bone width will likely occur 1 year after tooth loss, especially in the anterior maxilla. A great percentage of the process of alveolar bone resorption occurs within the first 3 to 6 months post-extraction. If ridge preservation is not conducted, 40%-60% of the total alveolar bone volume is lost during the first 2-3 years post-extraction, and this phenomenon has shown to continue to occur at a rate of 0.25%-0.5% loss per year. It has been proposed that ridge augmentation procedures may reduce the expected ridge reduction after tooth loss. Ridge augmentation procedures may require the use of bone grafts and non-resorbable or non-resorbable barrier membranes. The use of non-resorbable barrier membranes for ridge augmentation has the clinical disadvantage of needing a second procedure for its removal during the healing phase. Osteogen® plug (OPP) consists of a non-ceramic bone graft incorporated in type I bovine Achilles tendon collagen. OPP was first developed to serve as a one-step grafting solution for ridge preservation without the need for a barrier membrane

Description:

There will be two(2) groups of standardized treatment (tooth extractions will not take place for research purposes. The Periodontal clinic receives referred tooth extraction indications for treatment as part of the patient's overall treatment plan) evaluated for this study. Subjects will be randomized to either treatment a) standard of care treatment for tooth extraction and ridge augmentation procedures with Cytoplast GRB, or b) standard of the care treatment protocol and ridge augmentation procedures with Osteogen. Each individual extraction site of the enrolled subject will be randomly assigned to Group A and/or Group B for the ridge augmentation procedure. It is possible for a subject to be randomized to both treatment groups. Randomization is like a "coin toss" prior to the initiation of the surgical procedure. The "coin toss" will be to define the procedure to be conducted for the smallest tooth number first. A computer-generated randomization assignment has been populated for the ridge augmentation assignments. The surgical procedure will be conducted following standard procedures for tooth exodontia and ridge preservation.The selected individual sites will be subjected to the standard of care extraction protocol and then randomized to one of two(2) ridge augmentation procedures. Intra-oral photographs will be made at the same optic focal distance using a ruler which will be used to evaluate areas where the membrane is still exposed and not epithelized. At 20 weeks postoperatively, each study subject will return for implant placement in the ridge preservation area. Excess tissue will be collected if the subject has a standard of care implant-related procedure where tissue could need to be removed for implant placement purposes. For example, if a patient undergoes a tooth extraction, ridge augmentation, and implant placement then any portion of the excised tooth and connective tissue will be kept for later analyses of histology discovery. No additional tissue will be collected for research purposes. There will be one screening visit, a treatment visit, and 7 post-operative follow-up visits at 1, 2, 3, 4, 6, 8, and 20 weeks. Subjects will visit the clinic a total of eight (9) times. Of the 9 visits, 1 visit is standard of care, 3 visits are a combined standard of care and research procedure visits and 5 are strictly for research purposes. The nonabsorbable membranes in the control will be removed after 4-6 weeks in a most atraumatic manner with the help of a tweezer without disturbing the underlying new connective tissue formation. As there is no need for removal of the absorbable membrane in the experimental group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 11, 2021
• Est. primary completion date: January 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• UT Clinic Participates
• Participates that live within 100 miles of UTHSC.
• Participates at least 12 years of age. If participants are 13-14 years of age, the premolars and molars will be included in this study. #2-15 & #18-31.
• Participates willing to cooperate with the post-operative instructions;
• Participates with 2 or more (multiples of 2) teeth needing Maxillary/mandibular and anterior/posterior teeth extractions without restrictions due to the percentage of surface area after the extraction and not interfering with the tooth's alveolar soft tissue exposed surface area.
• Participates with the availability of returning for 8 visits for data collection.
• Participants are willing to cooperate with answering the VAS and taking standardized photographs.
• Participants are physically able to tolerate surgical procedures based on current medical history.
• Participates able to provide voluntary consent; read and understand English

Exclusion Criteria:

• Participates with Diabetes
• History of use of bisphosphonates
• Current smoker
• If the participant is 12-13 years of age, the tooth/teeth to be removed will not be a primary tooth due to the permanent teeth developing underneath the primary teeth.
• Pregnant and lactating women

Related Conditions & MeSH terms

• Alveolar Ridge Preservation

Intervention

Device:
• Osteogen plug®
A type I bovine Achilles tendon collagen with bioactive resorbable calcium apatite crystals (CCAC)
• MInerOss®
A cortico-cancellous bone chips mix with polytetrafluoroethylene (dPTFE)(Cytoplast) barrier membrane.

Locations

Country	Name	City	State
United States	University of Tennessee Health Science Center	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

References & Publications (18)

Araújo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. — View Citation

Ashman A. Postextraction ridge preservation using a synthetic alloplast. Implant Dent. 2000;9(2):168-76. Review. — View Citation

Barber HD, Lignelli J, Smith BM, Bartee BK. Using a dense PTFE membrane without primary closure to achieve bone and tissue regeneration. J Oral Maxillofac Surg. 2007 Apr;65(4):748-52. — View Citation

Beth-Tasdogan NH, Mayer B, Hussein H, Zolk O. Interventions for managing medication-related osteonecrosis of the jaw. Cochrane Database Syst Rev. 2017 Oct 6;10:CD012432. doi: 10.1002/14651858.CD012432.pub2. Review. — View Citation

Dahlin C, Linde A, Gottlow J, Nyman S. Healing of bone defects by guided tissue regeneration. Plast Reconstr Surg. 1988 May;81(5):672-6. — View Citation

Evian CI, Rosenberg ES, Coslet JG, Corn H. The osteogenic activity of bone removed from healing extraction sockets in humans. J Periodontol. 1982 Feb;53(2):81-5. — View Citation

Feng L, Zhang L, Cui Y, Song TX, Qiu ZY, Wang XM, Tan BS. Clinical evaluations of mineralized collagen in the extraction sites preservation. Regen Biomater. 2016 Mar;3(1):41-8. doi: 10.1093/rb/rbv027. Epub 2016 Jan 19. — View Citation

Fickl S, Schneider D, Zuhr O, Hinze M, Ender A, Jung RE, Hürzeler MB. Dimensional changes of the ridge contour after socket preservation and buccal overbuilding: an animal study. J Clin Periodontol. 2009 May;36(5):442-8. doi: 10.1111/j.1600-051X.2009.01381.x. — View Citation

Kosinski T. A Simple and Cost-Effective Socket Preservation Technique. Dent Today. 2016 Apr;35(4):90, 92, 94-5. — View Citation

Lekovic V, Camargo PM, Klokkevold PR, Weinlaender M, Kenney EB, Dimitrijevic B, Nedic M. Preservation of alveolar bone in extraction sockets using bioabsorbable membranes. J Periodontol. 1998 Sep;69(9):1044-9. — View Citation

McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a critical review. Psychol Med. 1988 Nov;18(4):1007-19. Review. — View Citation

Molnar JA, Lew WK, Rapp DA, Gordon ES, Voignier D, Rushing S, Willner W. Use of standardized, quantitative digital photography in a multicenter Web-based study. Eplasty. 2009;9:e4. Epub 2009 Jan 12. — View Citation

Nevins M, Camelo M, De Paoli S, Friedland B, Schenk RK, Parma-Benfenati S, Simion M, Tinti C, Wagenberg B. A study of the fate of the buccal wall of extraction sockets of teeth with prominent roots. Int J Periodontics Restorative Dent. 2006 Feb;26(1):19-29. — View Citation

Nevins M, Parma-Benfenati S, Janke UW, Kleyer A, Rasperini G, Tinti C, Schupbach P, Kim DM. The efficacy of mineralized allograft cortical and cancellous chips in maxillary sinus augmentations. Int J Periodontics Restorative Dent. 2014 Nov-Dec;34(6):789-93. doi: 10.11607/prd.1720. — View Citation

Park JC, Koo KT, Lim HC. The hidden X suture: a technical note on a novel suture technique for alveolar ridge preservation. J Periodontal Implant Sci. 2016 Dec;46(6):415-425. doi: 10.5051/jpis.2016.46.6.415. Epub 2016 Dec 26. — View Citation

Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23. — View Citation

Tallgren A. The continuing reduction of the residual alveolar ridges in complete denture wearers: a mixed-longitudinal study covering 25 years. 1972. J Prosthet Dent. 2003 May;89(5):427-35. — View Citation

Wang HL, Boyapati L. "PASS" principles for predictable bone regeneration. Implant Dent. 2006 Mar;15(1):8-17. Review. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological Bone Formation Changes	histomorphometric evaluation of the grafted bone. The area fraction (AF) of newly formed bone was measured automatically. The area fraction represents the percentage of the newly formed bone trabeculae to the total area of the microscopic field. The mean area fraction (MAF) for each case was calculated. Estimation of osteocytes count in each microscopic field, viable osteocytes within their lacunae in the newly formed bone	4 weeks
Primary	Histological Bone Formation Changes	histomorphometric evaluation of the grafted bone. The area fraction (AF) of newly formed bone was measured automatically. The area fraction represents the percentage of the newly formed bone trabeculae to the total area of the microscopic field. The mean area fraction (MAF) for each case was calculated. Estimation of osteocytes count in each microscopic field, viable osteocytes within their lacunae in the newly formed bone	6 weeks
Primary	Histological Bone Formation Changes	histomorphometric evaluation of the grafted bone. The area fraction (AF) of newly formed bone was measured automatically. The area fraction represents the percentage of the newly formed bone trabeculae to the total area of the microscopic field. The mean area fraction (MAF) for each case was calculated. Estimation of osteocytes count in each microscopic field, viable osteocytes within their lacunae in the newly formed bone	20 weeks
Primary	Clinical Dimensional Changes	Clinical evaluation of alveolar ridge bucco-lingually dimensional changes following alveolar ridge augmentation using standardized photography.; Clinical evaluation of alveolar ridge bucco-lingually dimensional changes following alveolar ridge augmentation using digital planimetry program, SigmaScan Pro 5.0.	4 weeks
Primary	Clinical Dimensional Changes	Clinical evaluation of alveolar ridge bucco-lingually dimensional changes following alveolar ridge augmentation using standardized photography.; Clinical evaluation of alveolar ridge bucco-lingually dimensional changes following alveolar ridge augmentation using digital planimetry program, SigmaScan Pro 5.0.	6 weeks
Primary	Clinical Dimensional Changes	Clinical evaluation of alveolar ridge bucco-lingually dimensional changes following alveolar ridge augmentation using standardized photography.; Clinical evaluation of alveolar ridge bucco-lingually dimensional changes following alveolar ridge augmentation using digital planimetry program, SigmaScan Pro 5.0.	20 weeks
Primary	Evaluate Patient Pain	Evaluate patient pain during the wound healing phase using the visual analog scale (VAS).; Scale range (0-10) : 0 1 2 3 4 5 6 7 8 9 10 Minimum Value: 0 = no pain Maximum Value: 10 = worse pain ever imaged	20 weeks