AzTrials
AzTrials

Alveolar Bone LossNCT03902457

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

A study testing Maxillary sinus augmentation in people with Alveolar Bone Loss, run by ARDEC Academy at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Alveolar Bone Loss
What is being tested?
Maxillary sinus augmentation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteColombia
Study dates
3 Feb 2016to 30 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • Colombia

    Cartagena, Cartagena, 5710

Other trials in Colombia

About this study

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.

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.

Read the detailed 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.

Being tested
Maxillary sinus augmentation
Keywords
maxillary sinus, collagen membrane, CBCT, Histology
Medical subject headings
Alveolar Bone Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maxillary sinus augmentationProcedure or surgery

    Also called maxillary sinus lift, maxillary sinus elevation

    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.

Study groups in NCT03902457
Study groupRoleWhat they receive
test siteExperimentalThe sinus mucosa will be elevated and, at the test sites, a collagen membrane will be placed subjacent the sinus mucosa
Receives: Procedure: Maxillary sinus augmentation
control siteExperimentalThe sinus mucosa will be elevated and, at the control sites, a collagen membrane will not be placed subjacent the sinus mucosa
Receives: Procedure: Maxillary sinus augmentation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (2)

  1. 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.

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2019
  2. Study start3 Feb 2016
  3. Primary completion30 Oct 2018
  4. Study completion30 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Clinical trial
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03902457
Sponsor's protocol ID
CBCT sinus membrane
Status last verified
Sep 2020
First submitted
30 Mar 2019
Last updated
5 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: the results will be published in a Journal

Publications

  • 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.

    PubMed 15152813

  • 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.

    PubMed 24071378

  • 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.

    PubMed 30144303

  • 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.

    PubMed 30521653

  • 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.

    PubMed 28593727

  • 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.

    PubMed 29876969

  • 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.

    PubMed 11794569

  • 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.

    PubMed 10453672

  • 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.

    PubMed 15726851

  • 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.

    PubMed 16448914

  • 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.

    PubMed 10356454

  • 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.

    PubMed 14703763

  • 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.

    PubMed 14620686

  • 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.

    PubMed 18351198

  • 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.

    PubMed 25247149

Questions about this trial

What is this clinical trial studying?

A study testing Maxillary sinus augmentation in people with Alveolar Bone Loss, run by ARDEC Academy at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changing in height of the elevated zone (time frame: The CBCTs will be taken before surgery (T0) and 1-week (T1) and 9 months (T2) after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03902457, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in