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

NCT03902457 | Completed DMC

• 1 other identifier: CBCT sinus membrane
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alveolar Bone Loss

Keywords

maxillary sinus; collagen membrane; CBCT; Histology

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• Changing in mucosa thickness

  The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery.

• New bone density around the mini-implant, from B to A and up to a distance of 400 µm from the implant surface.

  Mini-implants will be installed six months after sinus lifting and retrieved after three months of healing

Study Arms (2)

test site

EXPERIMENTAL

The sinus mucosa will be elevated and, at the test sites, a collagen membrane will be placed subjacent the sinus mucosa

Procedure: Maxillary sinus augmentation

control site

EXPERIMENTAL

The sinus mucosa will be elevated and, at the control sites, a collagen membrane will not be placed subjacent the sinus mucosa

Procedure: Maxillary sinus augmentation

Interventions

Maxillary sinus augmentation PROCEDURE

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.

Also known as: maxillary sinus lift, maxillary sinus elevation

control site; test site

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ARDEC Academy: lead
• Corporacion Universitaria Rafael Nunez: collaborator

Study Sites (1)

Colombia

Cartagena, Cartagena, 5710, Colombia

Location

Related Publications (18)

• 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. doi: 10.1902/jop.2004.75.4.511.

  PMID: 15152813 RESULT

• 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 Sep 24.

  PMID: 24071378 RESULT

• 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):e12362. doi: 10.1111/jicd.12362. Epub 2018 Aug 24.

  PMID: 30144303 RESULT

• 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/February;34(1):223-232. doi: 10.11607/jomi.7112. Epub 2018 Dec 5.

  PMID: 30521653 RESULT

• 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 Oral Implants Res. 2017 Dec;28(12):1567-1576. doi: 10.1111/clr.13027. Epub 2017 Jun 7.

  PMID: 28593727 RESULT

• 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: 10.1111/clr.13292. Epub 2018 Jun 7.

  PMID: 29876969 RESULT

• 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.

  PMID: 11794569 RESULT

• 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.

  PMID: 10453672 RESULT

• 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.

  PMID: 15726851 RESULT

• 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. doi: 10.1016/j.tripleo.2005.04.008. Epub 2005 Sep 19.

  PMID: 16448914 RESULT

• Pikos MA. Maxillary sinus membrane repair: report of a technique for large perforations. Implant Dent. 1999;8(1):29-34. doi: 10.1097/00008505-199901000-00003.

  PMID: 10356454 RESULT

• 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.

  PMID: 14703763 RESULT

• 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. doi: 10.1563/1548-1336(2003)0292.3.CO;2.

  PMID: 14620686 RESULT

• 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 Periodontics Restorative Dent. 2008 Feb;28(1):9-17.

  PMID: 18351198 RESULT

• 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.2014.40.4.188. Epub 2014 Aug 26.

  PMID: 25247149 RESULT

• 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 Res. 2016 Nov;27(11):1454-1461. doi: 10.1111/clr.12762. Epub 2016 Jan 11.

  PMID: 26754150 RESULT

• 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. Epub 2015 Feb 25.

  PMID: 25712609 RESULT

• 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. 2009 Jul;20(7):691-700. doi: 10.1111/j.1600-0501.2008.01697.x.

  PMID: 19453567 RESULT

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Sinus Floor Augmentation

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Bone Transplantation; Orthopedic Procedures; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: An author not involved in the surgeries will perform the randomization process. The assignments will be sealed within opaque envelopes that will be opened after the completion of the elevation of the sinus mucosa.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Clinical trial

Study Record Dates

• First Submitted: March 30, 2019
• First Posted: April 4, 2019
• Study Start: February 3, 2016
• Primary Completion: October 30, 2018
• Study Completion: December 30, 2018
• Last Updated: October 5, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: will be become available after the time required by the journal for publication and will be available all the time the journal is active.

Locations

CO (1)