Histomorphometric and Tomographic Assessment on the Influence of the Placement of a Collagen Membrane Subjacent the Sinus Mucosa After Maxillary Sinus Floor Augmentation

Alveolar Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03902457
• Other study ID #: CBCT sinus membrane
• Status: Completed
• Phase: N/A
• Start date: February 3, 2016
• Est. completion date: December 30, 2018

Study information

• Verified date: September 2020
• Source: ARDEC Academy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the purpose of the study is to look for differences in dimensional variations of augmented maxillary sinuses with or without the placement of a collagen membrane subjacent the sinus mucosa.

Description:

Material and Methods: After the elevation of the maxillary sinus mucosa, a collagen membrane with standard dimensions will be placed at the test sites subjacent the sinus mucosa and the elevated space will be filled with a xenograft, both test and control groups. A collagen membrane will be placed to cover the antrostomy at both groups and sutures will be provided to close the wound. After six months of healing, mini-implants will be installed. After 9 months, biopsies containing the mini-implants will be harvested for histomorphometric analyses. 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). Osseointegration of the mini-implants and dimensional changes over time of soft and hard tissues will be evaluated on the CBCTs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

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:

• 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

Intervention

Procedure:
• Maxillary sinus augmentation
Maxillary sinus augmentation procedures have become increasingly popular procedures before placement of dental implants in posterior maxillae that have suffered severe bone loss due to sinus pneumatization, alveolar bone atrophy, or trauma.

Locations

Country	Name	City	State
Colombia	Colombia	Cartagena de Indias	Cartagena

Sponsors (2)

Lead Sponsor	Collaborator
ARDEC Academy	Corporacion Universitaria Rafael Nunez

Country where clinical trial is conducted

Colombia, 

References & Publications (18)

Aimetti M, Romagnoli R, Ricci G, Massei G. Maxillary sinus elevation: the effect of macrolacerations and microlacerations of the sinus membrane as determined by endoscopy. Int J Periodontics Restorative Dent. 2001 Dec;21(6):581-9. — View Citation

Choi BH, Zhu SJ, Jung JH, Lee SH, Huh JY. The use of autologous fibrin glue for closing sinus membrane perforations during sinus lifts. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Feb;101(2):150-4. Epub 2005 Sep 19. — View Citation

Favero V, Lang NP, Canullo L, Urbizo Velez J, Bengazi F, Botticelli D. Sinus floor elevation outcomes following perforation of the Schneiderian membrane. An experimental study in sheep. Clin Oral Implants Res. 2016 Feb;27(2):233-40. doi: 10.1111/clr.12576 — View Citation

Iida T, Carneiro Martins Neto E, Botticelli D, Apaza Alccayhuaman KA, Lang NP, Xavier SP. Influence of a collagen membrane positioned subjacent the sinus mucosa following the elevation of the maxillary sinus. A histomorphometric study in rabbits. Clin Ora — View Citation

Kawakami S, Lang NP, Ferri M, Apaza Alccayhuaman KA, Botticelli D. Influence of the height of the antrostomy in sinus floor elevation assessed by cone beam computed tomography- a randomized clinical trial. Int J Oral Maxillofac Implants. 2019 January/Febr — View Citation

Kawakami S, Lang NP, Iida T, Ferri M, Apaza Alccayhuaman KA, Botticelli D. Influence of the position of the antrostomy in sinus floor elevation assessed with cone-beam computed tomography: A randomized clinical trial. J Investig Clin Dent. 2018 Nov;9(4):e — View Citation

Khoury F. Augmentation of the sinus floor with mandibular bone block and simultaneous implantation: a 6-year clinical investigation. Int J Oral Maxillofac Implants. 1999 Jul-Aug;14(4):557-64. — View Citation

Kim YK, Yun PY, Oh JS, Kim SG. Prognosis of closure of large sinus membrane perforations using pedicled buccal fat pads and a resorbable collagen membrane: case series study. J Korean Assoc Oral Maxillofac Surg. 2014 Aug;40(4):188-94. doi: 10.5125/jkaoms. — 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

Nolan PJ, Freeman K, Kraut RA. Correlation between Schneiderian membrane perforation and sinus lift graft outcome: a retrospective evaluation of 359 augmented sinus. J Oral Maxillofac Surg. 2014 Jan;72(1):47-52. doi: 10.1016/j.joms.2013.07.020. Epub 2013 — 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

Pikos MA. Maxillary sinus membrane repair: report of a technique for large perforations. Implant Dent. 1999;8(1):29-34. — View Citation

Proussaefs P, Lozada J, Kim J. Effects of sealing the perforated sinus membrane with a resorbable collagen membrane: a pilot study in humans. J Oral Implantol. 2003;29(5):235-41. — View Citation

Proussaefs P, Lozada J. The "Loma Linda pouch": a technique for repairing the perforated sinus membrane. Int J Periodontics Restorative Dent. 2003 Dec;23(6):593-7. — View Citation

Scala A, Lang NP, Velez JU, Favero R, Bengazi F, Botticelli D. Effects of a collagen membrane positioned between augmentation material and the sinus mucosa in the elevation of the maxillary sinus floor. An experimental study in sheep. Clin Oral Implants R — View Citation

Schwartz-Arad D, Herzberg R, Dolev E. The prevalence of surgical complications of the sinus graft procedure and their impact on implant survival. J Periodontol. 2004 Apr;75(4):511-6. — View Citation

Testori T, Wallace SS, Del Fabbro M, Taschieri S, Trisi P, Capelli M, Weinstein RL. Repair of large sinus membrane perforations using stabilized collagen barrier membranes: surgical techniques with histologic and radiographic evidence of success. Int J Pe — View Citation

Zijderveld SA, Schulten EA, Aartman IH, ten Bruggenkate CM. Long-term changes in graft height after maxillary sinus floor elevation with different grafting materials: radiographic evaluation with a minimum follow-up of 4.5 years. Clin Oral Implants Res. 2 — View Citation

* Note: There are 18 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	Measurements will be assessed in the medial, middle and lateral regions of the elevated zone using 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.
Primary	New bone-to-implant contact	Measurements will be assessed between the most coronal (B) and the most apical (A) contacts of new bone to the implant surface.	Mini-implants will be installed six months after sinus lifting and retrieved after three months of healing.
Secondary	Changing in mucosa thickness	Measurements will be assessed in the cone beam computerized tomographies (CBCTs) taken in various periods. Comparisons among the CBCTs of each participants will be performed.	The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery.
Secondary	New bone density around the mini-implant, from B to A and up to a distance of 400 µm from the implant surface.	Measurements will be assessed using a point counting procedure, superposing a lattice with squares of 50 µm over the histological image.	Mini-implants will be installed six months after sinus lifting and retrieved after three months of healing