Tomographic and Histologic Assessment on the Influence of the Use of a Collagen Membrane to Protect the Antrostomy After Maxillary Sinus Floor Augmentation.

Alveolar Bone Loss Clinical Trial

Official title:

Cone Beam Computed Tomography and Histomorphometric Assessments on the Influence a Collagen Membrane Placed on the Antrostomy After Maxillary Sinus Floor Augmentation. A Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03899688
• Other study ID #: CBCT
• Status: Completed
• Phase: N/A
• Start date: February 20, 2015
• Est. completion date: March 2, 2019

Study information

• Verified date: January 2022
• Source: ARDEC Academy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the aim of the present study was to evaluate the dimensional variation and osseointegration of mini-implants at augmented sinus with the antrostomy left unprotected or protected with a collagen membrane.

Description:

The Schneiderian mucosa will be elevated and the created space will be filled with a natural bovine bone grafting material (Cerabone® 1-2 mm, Botiss Biomaterials GmbH). In ten patients randomly selected (control sties), a native collagen membrane made of porcine dermis (Collprotect®, Botiss Biomaterials GmbH) will be placed on the antrostomy. In another ten patients of the test group, the antrostomy will be left without the membrane. The flaps will be sutured and anti-inflammatory drugs and antibiotics will be administrated to the patients. The sutures will be removed after 7 days. After 6 months of healing, two mini-implants with different surface will be installed and retrieved after further 3 months for histomorphometric evaluations. CBCTs will be taken for all patients before surgery (T0), after 1 week from sinus floor augmentation (T1) and after 9 months of healing (T2) and evaluation of dimensional variations over time of soft and hard tissues will be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2, 2019
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Presence of an edentulous atrophic zone in the posterior segment of the maxilla
• Height of the sinus floor =4 mm.
• Desiring a prosthetic restoration of the zone using a fix prosthesis supported by implants
• = 21 years of age
• Good general health
• No contraindication for oral surgical procedures
• Not being pregnant.

Exclusion Criteria:The patients will be excluded if they present:

• A systemic disordered.
• Had a chemotherapic or radiotherapeutic treatment.
• Are smokers >10 cigarettes per day
• Have an acute or a chronic sinusitis.
• Had a previous bone augmentation procedures in the zone of interest.

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Alveolar Bone Resorption
• Bone Resorption

Intervention

Procedure:
• Maxillary sinus augmentation
Surgical technique for increasing the vertical bone height of the posterior maxilla an antrostomy of about 5 mm in height and 10 mm long will be prepared using a diamond insert mounted on a sonic-air surgical instrument. The Schneiderian membrane will be elevated and clinical measurements will be performed using an UNC 15 probe. The space obtained underneath the sinus mucosa will be filled with the xenograft and a resorbable collagen membrane will be placed to cover the antrostomy only at the randomly selected control sites.

Locations

Country	Name	City	State
Colombia	Colombia	Cartagena de Indias	Cartagena

Sponsors (1)

Lead Sponsor	Collaborator
ARDEC Academy

Country where clinical trial is conducted

Colombia, 

References & Publications (12)

Barone A, Ricci M, Grassi RF, Nannmark U, Quaranta A, Covani U. A 6-month histological analysis on maxillary sinus augmentation with and without use of collagen membranes over the osteotomy window: randomized clinical trial. Clin Oral Implants Res. 2013 J — View Citation

Caneva M, Lang NP, Garcia Rangel IJ, Ferreira S, Caneva M, De Santis E, Botticelli D. Sinus mucosa elevation using Bio-Oss(®) or Gingistat(®) collagen sponge: an experimental study in rabbits. Clin Oral Implants Res. 2017 Jul;28(7):e21-e30. doi: 10.1111/c — View Citation

Corbella S, Taschieri S, Weinstein R, Del Fabbro M. Histomorphometric outcomes after lateral sinus floor elevation procedure: a systematic review of the literature and meta-analysis. Clin Oral Implants Res. 2016 Sep;27(9):1106-22. doi: 10.1111/clr.12702. — View Citation

Cricchio G, Sennerby L, Lundgren S. Sinus bone formation and implant survival after sinus membrane elevation and implant placement: a 1- to 6-year follow-up study. Clin Oral Implants Res. 2011 Oct;22(10):1200-1212. doi: 10.1111/j.1600-0501.2010.02096.x. — View Citation

De Santis E, Lang NP, Ferreira S, Rangel Garcia I Jr, Caneva M, Botticelli D. Healing at implants installed concurrently to maxillary sinus floor elevation with Bio-Oss(®) or autologous bone grafts. A histo-morphometric study in rabbits. Clin Oral Implant — View Citation

Lundgren S, Andersson S, Gualini F, Sennerby L. Bone reformation with sinus membrane elevation: a new surgical technique for maxillary sinus floor augmentation. Clin Implant Dent Relat Res. 2004;6(3):165-73. — View Citation

Masuda K, Silva ER, Botticelli D, Apaza Alccayhuaman KA, Xavier SP. Antrostomy Preparation for Maxillary Sinus Floor Augmentation Using Drills or a Sonic Instrument: A Microcomputed Tomography and Histomorphometric Study in Rabbits. Int J Oral Maxillofac — View Citation

Moon YS, Sohn DS, Moon JW, Lee JH, Park IS, Lee JK. Comparative histomorphometric analysis of maxillary sinus augmentation with absorbable collagen membrane and osteoinductive replaceable bony window in rabbits. Implant Dent. 2014 Feb;23(1):29-36. doi: 10 — View Citation

Omori Y, Ricardo Silva E, Botticelli D, Apaza Alccayhuaman KA, Lang NP, Xavier SP. Reposition of the bone plate over the antrostomy in maxillary sinus augmentation: A histomorphometric study in rabbits. Clin Oral Implants Res. 2018 Aug;29(8):821-834. doi: — View Citation

Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2 — View Citation

Riachi F, Naaman N, Tabarani C, Aboelsaad N, Aboushelib MN, Berberi A, Salameh Z. Influence of material properties on rate of resorption of two bone graft materials after sinus lift using radiographic assessment. Int J Dent. 2012;2012:737262. doi: 10.1155 — View Citation

Shanbhag S, Shanbhag V, Stavropoulos A. Volume changes of maxillary sinus augmentations over time: a systematic review. Int J Oral Maxillofac Implants. 2014 Jul-Aug;29(4):881-92. doi: 10.11607/jomi.3472. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changing in height of the elevated zone.	will be assessed in the medial, middle and lateral regions of the elevated zone using the cone beam computerized tomographies	The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery
Primary	Bone-to-implant contact between the different surfaces and between membrane / no membrane groups	Measurements of new bone formation will be assessed on the histological images taken from the slides and performed between the most coronal bone contact to the surface and the apex of the mini-implant. Comparisons among test and control (without or with a collagen membrane of the access window) and between the two different surface conformations will be performed	three months of healing
Secondary	Changing in area of the elevated zone	The area will be delineated by the sinus bone walls and the sinus mucosa. The changes will be evaluated on the cone beam computerized tomographies (CBCTs) taken in various periods.	The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery
Secondary	Bone density	Measurements of new bone formation will be assessed on the histological images taken from the slides and performed between the most coronal bone contact to the surface and the apex of the mini-implant. Comparisons among test and control (without or with a collagen membrane of the access window) and between the two different surface conformations will be performed.	three months of healing