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Socket PreservationNCT03573193

Radiographic Changes Following Socket Preservation in Molars Using Bovine Bone Versus Using Beta Tri ca.ph

A study testing ridge preservation in people with Socket Preservation, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Inadequate ridge width to allow implant placement, it noted that when extraction takes place and ridge preservation is not utilized the site of extraction could lose 40% to 60% of bone height and width within 2 to 3 years and subsequent loss of 0.25% to 0.5% annually. Read more about this study

Who is it for?
Ages 25 to 60 years
Conditions the study is for
Socket Preservation
What is being tested?
ridge preservation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Jul 2018to 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 25 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Good oral hygiene.
  • Age from 25-60 years
  • Both sexes
  • Sufficient bone volume
  • Presence of non-restorable mandibular molars.

Who cannot join

  • Extreme bone atrophy.
  • Patients who have systemic disorders that might interfere with bone metabolism.
  • Pregnant patients.
  • Bad oral hygiene.
  • Patients with bone diseases.
  • Patient with limited mouth opening

Trial locations and contacts

No sites are listed yet.

wahid Y al hussiney, B.D.S contact

01006881803 ext. 002

waw2sad@yahoo.com

mohammed A abd rassoul, p.h.d contact

01009612708 ext. 002

About this study

Official title: Radiographic Bone Changes Following Socket Preservation in Mandibular Molars Using Deproteinized Bovine Bone Mineral Versus Using Beta Tri Calcium Phosphate

Inadequate ridge width to allow implant placement, it noted that when extraction takes place and ridge preservation is not utilized the site of extraction could lose 40% to 60% of bone height and width within 2 to 3 years and subsequent loss of 0.25% to 0.5% annually. it reported as much as 4 mm loss of ridge width in extraction alone sites within 6 months. Using an atraumatic tooth extraction technique preserves osseous walls thereby improving the chances of osseous graft success.

The goal of ridge preservation is minimizing bone loss to preserve the maximum final, healed ridge dimensions.

Socket preservation is done using a hard tissue graft like xenograft bone or synthetic bone substitutes and prevent hazard of surgical intervention which needed during implant loading due to bone resorption.

Read the detailed description

Good assessment whether a particular graft is more beneficial than others which can be improve the extraction site healing.

Good assessment if grafting has any beneficial or detrimental effects on post-operative sequelae post extraction.

Extraction is indicated when a tooth cannot be restored or maintained in suitable conditions for long-term health, function, and/or esthetics. Loss of a tooth has a direct effect on life quality by impairing the ability to masticate, speak, and, in some instances, socialize, after tooth extraction an average alveolar bone loss of 1.5-2 mm (vertical) and 40%-50% (horizontal) occurs within 6 months, alveolar dimensional changes occur during the first 3 months. If no treatment to restore the dentition is provided, then continued bone loss occurs and up to 40%-60% of ridge volume is lost in first 3 years . And the absence of a tooth in its alveolus enhances a cascade of biological events that typically result in significant local anatomic changes..

Studies have demonstrated that loss of alveolar ridge Post extraction is an irreversible process result in both horizontal and vertical reduction. Atrophy of alveolar ridge may have a significant effect on tooth replacement therapy, especially when implant restorations are planned.

Therefore, alveolar ridge preservation has become a key component of contemporary clinical dentistry.

Past therapy attempts to prevent resorption of alveolar ridge were performed by root retention, with the primary goal of maximizing the stability of removable prostheses. In spite of that, root retention is not always practical because of fracture, caries, and/or strategic reasons.

Alveolar ridge preservation via "socket grafting" started in the mid-1980s as a therapeutic alternative to root submergence. Its use was rationalized on the opinion that "filling" the space left by the extracted tooth with a biomaterial would simulate a "root retention effect" conducive to bone preservation, which would subsequently facilitate placement of implant by reducing the need of additional grafting procedures. This approach gained popularity over the years because of its conceptual attractiveness and simple technical procedures.

Over the past twenty years, multiple studies evaluating the efficacy of different socket-filling access have been conducted. In these studies, many of biomaterials have been employed, including autologous bone, bone substitutes (allografts, xenografts, and alloplasts), bioactive agents, and autologous blood-derived products.

Use of a grafting material with or without a membrane (alveolar ridge preservation) give additional support for stabilization of blood clot and space maintenance, bone loss is reduced from 69% to 25% or less. Objective of alveolar ridge preservation reduces bone loss, reduce the need for additional bone, and provide soft tissue support. And sinus augmentation procedures . finally providing for easier implant placement and a higher potential of achieving an esthetic restorative outcome.

Ridge preservation procedures are indicated when buccal plate thickness less than 1.5-2mm (most anterior and esthetic zones), damage or loss of one or more socket walls, maintaining bone volume is crucial to minimize the risk to adjacent anatomical structures, patients where many teeth are being extracted and preservation of bone is important for further restoration, and patients with high esthetic demands such as a high lip line and thin biotype, which are more prone to tissue loss.

Xenogenic Bone Grafts (Xenografts): Xenografts are derived from other species; Grafts are harvested from animals, mainly cows. That is why this is processed to make it totally biocompatible and sterile.

Advantages of xenografts:

  • Only one simple procedure is needed as the bone is not being harvested from the patient in dangerous surgical procedures and it will encourage Natural bone growth.

Disadvantage of xenografts:

Is the minimal risk of bovine sponge form encephalopathy due to the fact that all organic components of the bone are extracted? The most widely used xenograft bone is deproteinized bovine bone mineral. Xenograft bone has similar properties to human cancellous bone, in its crystalline content and its macrostructure; it also has similar physical properties to the human bone This is a purely mineral graft and is osteoconductive but also some resorption will happen, so its use also has limitation. When used in a particulate form it is mixed with the patient's blood and packed into the defect.

They are materials with their organic components totally removed, With their removal, concern about immunological reactions becomes nonexistent, The remaining inorganic structure provides a natural architectural matrix as well as an excellent source of calcium The inorganic material also maintains the physical dimension of the augmentation during the remodeling phases.

choice of comparators: Alloplasts are synthetic bone substitutes. They are made of inorganic biocompatible materials including synthetic hydroxyapatite, tricalcium phosphate, bioactive glass, and calcium carbonate. Whether synthetic hydroxyapatite is resorbable or nonresorbable depends on the temperature at which it is prepared.

High-temperature preparation of hydroxyapatite results in a nonresorbable, dense material, nonporous, which is used as filler. Tricalcium phosphate acts as filler and is partially resorbable. Calcium carbonate, which is derived from coral, is biocompatible and resorbable so that it acts as filler, which eventually may be replaced by new bone. Bioactive glass is a silicone-based, osteoconductive material that bonds to bone through the formation of carbonated hydroxyapatite.

The advantage of alloplasts is that they have no potential for disease transmission.

Among the most promising is the tricalcium phosphate , an alloplastic ceramic material studied and used extensively in the past decade. It is considered to be bioactive (by means of inducing specific biologic reactions) and (not stimulating inflammatory or foreign-body giant cell activity) biocompatible.

This is mainly because tricalcium phosphate is composed of Ca and P ions, which are the most commonly found elements in bone. However, tricalcium phosphate cements have a slower resorption rate than bone and are usually too dense to allow bone tissue to grow into the defect in a limited period of time.

By adding a faster resorbing material, pores may be created, ensuring new bone tissue growing into the defect.

Tricalcium phosphate as a bone graft substitute has been evaluated at length in previous studies. It binds to bone by means of mechanical anchorage with no formation of intermediate apatite layer. Bioresorption of tricalcium phosphate granules occurs due to chemical dissolution in biological fluids and cellular degradation.

Solubilization is induced by mesenchymal cells, which are also actively involved in the degradation process.

the capability of osteoplastic cells, fibroblasts, and osteoclasts to degrade TCP ceramic material. Monocyte/macrophage participation is well documented in vivo as well as in vitro.

It seems that the more soluble a CaP ceramic, the more rapidly it is resorbed by osteoclasts. However, the increased number of released calcium ions may, on one hand, inhibit osteoclasts' activity, while on the other hand, it provides a good environment for osteogenesis. Therefore, it seems that Tricalcium phosphate resorption is performed at a rather unpredictable rate that does not always correspond to the new bone formation rate. This behavior is evident in the conflicting results of many studies on the bioresorption of TCP.

The βeta- phase isomer of Tricalcium phosphate (β -Tricalcium phosphate ), however, is characterized by homogenous microporosity, physiologic pH, increased solubility, and a more predictable resorption rate that look alike the new bone remodeling rate. Composition or impurities Variations may affect solubility, whereas the pure phase seems to be resorbed in 5 to 6 months.

It should be noted that a faster resorbable material might allow soft-tissue cells to prematurely intrude into the defect, while slowly resorbable or nonresorbable materials that remain for a long time may inhibit new bone deposition.

Being tested
ridge preservation
Keywords
xenograft bone, synthetic bone substitutes

What participants receive

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

  • ridge preservationOther

    Intra operative procedures (for both groups) ridge preservation

    • Local anesthesia will be given to the patient.
    • Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
    • A crestal incision was made, and a mucoperiosteal flap was elevated. Implant osteotomies were prepared according to the recommendations and desired dimensions of implants.
    • In study group: tooth extraction with ridge preservation using deproteinized bovine bone mineral Bio-Oss
    • In the comparators group: tooth extraction with ridge preservation using an alloplastic ceramic material beta tricalcium phosphate (TCP).
Study groups in NCT03573193
Study groupRoleWhat they receive
study group:Active comparatorridge preservation alveolar ridge socket preserved using alloplastic material beta tri calcium phosphate type
Receives: Other: ridge preservation
control groupOtherridge preservation (alveolar ridge socket preserved using xenograft material Bio-oss type
Receives: Other: ridge preservation

What is being measured

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

  1. Prevent post extraction ridge volume loss and decrease bone resorption detected by CBCT to prepare for success implant loading

    socket preservation is minimizing bone loss to preserve the maximum final, healed ridge dimensions

    Measured: base lline

Timeline

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

  1. First posted29 Jun 2018
  2. Study startJul 2018 (estimated)
  3. Primary completionNov 2018 (estimated)
  4. Study completionDec 2018 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized clinical trial. • Unicenter, single blinded, with equal randomization, active controlled, parallel group study
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03573193
Sponsor's protocol ID
socket preservation
Status last verified
Jun 2018
First submitted
13 Jun 2018
Last updated
29 Jun 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gerritsen AE, Allen PF, Witter DJ, Bronkhorst EM, Creugers NH. Tooth loss and oral health-related quality of life: a systematic review and meta-analysis. Health Qual Life Outcomes. 2010 Nov 5;8:126. doi: 10.1186/1477-7525-8-126.

    PubMed 21050499
  • 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.

    PubMed 12956475
  • Van der Weijden F, Dell'Acqua F, Slot DE. Alveolar bone dimensional changes of post-extraction sockets in humans: a systematic review. J Clin Periodontol. 2009 Dec;36(12):1048-58. doi: 10.1111/j.1600-051X.2009.01482.x.

    PubMed 19929956
  • Seibert JS, Salama H. Alveolar ridge preservation and reconstruction. Periodontol 2000. 1996 Jun;11:69-84. doi: 10.1111/j.1600-0757.1996.tb00185.x. No abstract available.

    PubMed 9567959
  • Osburn RC. Preservation of the alveolar ridge: a simplified technique for retaining teeth beneath removable appliances. J Indiana State Dent Assoc. 1974 Jan-Feb;53(1):8-11. No abstract available.

    PubMed 4523604
  • Artzi Z, Nemcovsky CE. The application of deproteinized bovine bone mineral for ridge preservation prior to implantation. Clinical and histological observations in a case report. J Periodontol. 1998 Sep;69(9):1062-7. doi: 10.1902/jop.1998.69.9.1062.

    PubMed 9776036
  • Christensen GJ. Ridge preservation: why not? J Am Dent Assoc. 1996 May;127(5):669-70. doi: 10.14219/jada.archive.1996.0279.

    PubMed 8642146
  • Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:260-71.

    PubMed 19885449
  • Tallgren A. The continuing reduction of the residual alveolar ridges in complete denture wearers: a mixed-longitudinal study covering 25 years. J Prosthet Dent. 1972 Feb;27(2):120-32. doi: 10.1016/0022-3913(72)90188-6. No abstract available.

    PubMed 4500507
  • Hammerle CH, Araujo MG, Simion M; Osteology Consensus Group 2011. Evidence-based knowledge on the biology and treatment of extraction sockets. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:80-2. doi: 10.1111/j.1600-0501.2011.02370.x.

    PubMed 22211307
  • De Buitrago JG, Avila-Ortiz G, Elangovan S. Quality assessment of systematic reviews on alveolar ridge preservation. J Am Dent Assoc. 2013 Dec;144(12):1349-57. doi: 10.14219/jada.archive.2013.0070.

    PubMed 24282264
  • Omran M, Min S, Abdelhamid A, Liu Y, Zadeh HH. Alveolar ridge dimensional changes following ridge preservation procedure: part-2 - CBCT 3D analysis in non-human primate model. Clin Oral Implants Res. 2016 Jul;27(7):859-66. doi: 10.1111/clr.12701. Epub 2015 Oct 25.

    PubMed 26498407
  • Barone A, Orlando B, Cingano L, Marconcini S, Derchi G, Covani U. A randomized clinical trial to evaluate and compare implants placed in augmented versus non-augmented extraction sockets: 3-year results. J Periodontol. 2012 Jul;83(7):836-46. doi: 10.1902/jop.2011.110205. Epub 2011 Dec 5.

    PubMed 22141358
  • Rasperini G, Canullo L, Dellavia C, Pellegrini G, Simion M. Socket grafting in the posterior maxilla reduces the need for sinus augmentation. Int J Periodontics Restorative Dent. 2010 Jun;30(3):265-73.

    PubMed 20386783
  • Darby I, Chen S, De Poi R. Ridge preservation: what is it and when should it be considered. Aust Dent J. 2008 Mar;53(1):11-21. doi: 10.1111/j.1834-7819.2007.00008.x.

    PubMed 18304236

Questions about this trial

What is this clinical trial studying?

A study testing ridge preservation in people with Socket Preservation, run by Cairo University.

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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact wahid Y al hussiney, B.D.S (01006881803 ext. 002, waw2sad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevent post extraction ridge volume loss and decrease bone resorption detected by CBCT to prepare for success implant loading (time frame: base lline). 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 NCT03573193, which also lists 33 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 29 Jun 2018.

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