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Alveolar Ridge AugmentationNCT03879967

Lateral Ridge Augmentation Using Allograft Blocks and GBR for Implant Sites

A study testing Allograft block graft in people with Alveolar Ridge Augmentation, run by University of Bern at 1 site in Switzerland.

Completed

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

Official record
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Trial summary

Clinicians are increasingly faced with the challenge of reconstructing the alveolar ridge as more patients desire fixed implant-supported restorations. Reconstruction of large horizontal alveolar defects still remains a challenge in implantology. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Alveolar Ridge Augmentation
What is being tested?
Allograft block graft
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteSwitzerland
Study dates
11 Jun 2013to 14 May 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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Atrophy of the alveolar ridge in the horizontal plane (<4 mm in posterior sites and <5 mm in anterior sites), or a crest width 5 mm in esthetic sites.
  • Patients who agree to sign an informed consent.

Who cannot join

  • Patients who had adequate horizontal ridge thickness and did not require ridge augmentation
  • Patients with deficient vertical height of the ridge requiring vertical augmentation
  • Patients who were not ready for implant supported prosthesis

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Department of Oral Surgery and Stomatology, ZMK, University of Bern

    Bern, 3010

Other trials in Switzerland

About this study

Official title: Lateral Ridge Augmentation Using Allograft Blocks and Guided Bone Regeneration for Implant Sites

Clinicians are increasingly faced with the challenge of reconstructing the alveolar ridge as more patients desire fixed implant-supported restorations. Reconstruction of large horizontal alveolar defects still remains a challenge in implantology. Although autogenous blocks from intraoral sites are proven effective for such defects, donor site morbidity and limited graft availability are major limitations. Allogenic bone blocks have been proposed to overcome these limitations, however, the outcomes reported in the literature are inconclusive. In this case series, the efficacy of allogenic blocks for lateral augmentation of atrophic ridges was evaluated, over a three-year period.

In nineteen edentulous sites from ten patients, cortico-cancellous allogenic blocks (PHOENIX, TBF, France) were shaped to the defect and screw-fixated. A double-layer of autogenous chips and demineralized bovine bone (Bio-Oss, Geistlich Pharma AG, Switzerland) was used to fill the voids. The augmented site was covered by non-cross-linked collagen membrane (Bio-Gide, Geistlich Pharma AG, Switzerland). After a healing period of 9 months, implants were placed and CBCT analysis was performed post-implantation. Following a period of 34 months of function (range 22 to 44 months), patients were clinically and radiographically re-examined.

Read the detailed description

The present study design is a mono-center three-year follow-up case series study to examined the safety and effectiveness of allograft bone blocks combined with guided bone regeneration (GBR). The study was in accordance to the principles of the Declaration of Helsinki and was approved by the standing ethical committee of the state of Bern, Switzerland.

The preoperative analysis included a complete medical history, clinical examination of the dentition and a thorough analysis of the implant recipient using 3D cone beam computed tomography (3D Accuitomo 170, Morita, Kyoto, Japan).

Surgical Procedure:

The surgical procedures were done in two stages. In the first stage surgery, a full-thickness mucoperiosteal flap was raised on both the facial and palatal aspects. Ridge augmentation was done using a mineralized, cortico-cancellous, delipidized, lyophilized allogenic block (ALB ; PHOENIX allograft, TBF Mions, France). Following hydration of the ALB, the cortico-cancellous part of the block was shaped to fit the recipient site and fixated by two fixation screws (Medartis, Modus, Medartis Holding AG, Basel, Switzerland). Voids around the ALB were filled with autogenous bone chips (AGB) harvested locally from the recipient site. The augmented site was covered by a first layer of deproteinized bovine bone mineral mixed (DBBM; Bio- Oss, Geistlich Pharma, Wolhusen, Switzerland and a non-crosslinked collagen membrane (BG; Bio- Gide, Geistlich AG, Wolhusen, Switzerland) as described previously (Chappuis et al DOI 10.1111/cid.12438). A periosteal-releasing incision was used to provide tension-free flap closure. The wound margins were approximated using non-resorbable poly- amide suture (Seralon, Serag-Wiessner GmbH, Naila, Germany) to obtain primary wound closure. All patients were prescribed an antibiotic regimen with 2g of amoxicillin with clavulanic acid 1 hour preoperatively to be continued as 1g twice daily for 3 days post-surgery. Patients were also prescribed analgesics and chlorhexidine digluconate (0.2%) for chemical plaque control. In patients with post-surgical complications the antibiotic regimen was prolonged. Sutures were removed around 14 days postoperatively. Removable provisionals were adapted, but patients were instructed to not to wear them unless unavoidable during the initial healing phase.

The second stage surgery was performed after a minimal healing period of six months (range 6 to 13months for me this would belong to the results). A paracrestal incision was given to elevate a full thickness mucoperiosteal. The fixation screws from the previous surgery were removed and the implant bed was prepared based on the specific requirements of the site. All implants placed had chemically modified, sandblasted, and acid-etched surface and had either, a tissue level implant (TL) or a bone level implant (BL) design (SLActive, Straumann AG, Basel, Switzerland). Simultaneous re-grafting was performed as required using autogenous bone chips, DBBM and a non-cross linked collagen membrane. A tension-free wound closure was obtained by non-resorbable sutures. The antibiotic and analgesic regimen and post-surgical care as the same as in the first-stage surgery. Sutures were removed after 14 days. Patients were instructed to wear the provisional with caution. After the healing period of 4-6 months the healing abutments were placed for the future prosthetics. The implants were restored with either single-unit crowns (SC), crowns with extensions (SC-E), bridges (B), bridges with extensions (B-E) or ball abutments (BA). All restorations were screw-retained. Patient were given oral hygiene instructions and directed to enroll onto a supportive periodontal therapy to monitor oral health.

Clinical and radiographic follow-up examination after 3 years:

Clinical parameters - Updates on medical conditions, smoking, oral hygiene and enrollment in a maintenance care program were collected from the patients. Clinical examinations were taken by the same examiner (VC) throughout the three-year follow-up period. The clinical parameters were assessed as previously described (Chappuis et al DOI 10.1111/cid.12438): peri-implant suppuration, modified plaque index (mPLI), modified sulcus bleeding index (mBLI), probing depth, DIM (distance from the implant shoulder to the mucosal margin), width of the KM, mobility and full mouth plaque scores.

Radiographic analysis using 2D radiographs and 3D CBCT - The peri-implant bone loss was measured on periapical 2D radiographs analysing the proximal DIB values as the vertical distance from the implant shoulder to the first bone-to-implant contact as described earlier (DIB; mm) (Weber HP et al 1992). The mean DIB value per implant considered was the average of the mesial and distal values.

The horizontal bone gain of the atrophic sites was assessed by with the smallest field of view (3D Accuitomo 170, Morita, Kyoto, Japan). The image analysis was performed by a high-resolution screen, using a specialised software (i-Dixel, Morita, Kyoto, Japan). The 3D analysis included a preoperative analysis of the proposed implant site. A standard reference point, 4mm crestal to the shoulder of the future implant was used for all measurements (Chappuis 2017). CBCT measurements were repeated prior to implant placement, using the same reference point and repeated again at the 2-3year follow-up appointment. The radiographic measurements were done by one examiner (OE).

Assessment of biological, technical complications and patient reported outcome measures (PROMS) - All events of complications, intra-operative and post-operative at each surgical phase (graft surgery and implant surgery), prior to prosthetic treatment and post prosthetic rehabilitation both operator-assessed and self-reported were recorded.

Patient reported outcome measures were assessed by the Oral Health Impact Profile (OHIP) scores and patient satisfaction scores based on a visual analog scale (VAS) were recorded for each patient after the entire treatment was completed and the patients received the prosthetic replacements.

Statistical Analysis:

All data sets were first analysed descriptively and were expressed as mean values with standard deviation. A repeated measures design was chosen and a linear mixed model was fitted for each single factor to assess its impact on the final outcome and co-relations were evaluated. Throughout, p-values less than 0.05 were considered as statistically significant. p-values were not corrected for multiple testing due to the explorative nature of this study. The statistical analysis was performed with the software package R (Version 3.5.1, R Foundation for Statistical Computing, Vienna, Austria).

Being tested
Allograft block graft
Keywords
Allograft block, guided bone regeneration, implants

What participants receive

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

  • Allograft block graftDevice

    The graft used is a mineralized, cortico-cancellous, delipidized, lyophilized allogenic block.

Study groups in NCT03879967
Study groupRoleWhat they receive
Allograft block graftExperimentalFor lateral alveolar ridge augmentation, all patients will be treated with allograft block with guided bone regeneration. After a minimal healing phase of six months, implants would be placed in the augmented site. After a healing phase of about 4months, the implants would be loaded and then followed until the control appointment approximately 3 years later.
Receives: Device: Allograft block graft

What is being measured

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

  1. Change in ridge thickness with use of the allograft block

    The change in ridge thickness was measured in mm at a specific reference point 4mm apical to the shoulder of the implant. The measurements were done from a CBCT image in the coronal/sagittal plane.

    Measured: The measurements were done at approximately 9 months after ridge augmentation surgery and prior to implant placement.

  2. Change in ridge thickness with use of the allograft block after implant placement

    The change in ridge thickness was measured in mm at a specific reference point 4mm apical to the shoulder of the implant. The measurements were done from a CBCT image in the coronal/sagittal plane.

    Measured: The measurements were done at the follow-up appointment approximately 3years after implant placement.

Secondary outcomes (15)
  1. Peri-implant suppuration

    Measured by palpation and probing

    Measured: Recorded at the 3years follow-up time point

  2. Modified plaque index by Mombelli

    Measured visually and with a periodontal probe. Assessed at four aspects around the implants mesial, distal, buccal and lingual.

    score 0, no detection of plaque; score 1, plaque only recognized by running a probe across the smooth marginal surface of the implant; score 2, plaque can be seen by the naked eye; and score 3, abundance of soft matter. The average of the four scores, gives the Modified plaque index for the implant

    Measured: Recorded at the 3years follow-up time point

  3. Modified sulcus bleeding index by Mombelli

    Measured visually and with a periodontal probe.Measured visually and with a periodontal probe. Assessed at four aspects around the implants mesial, distal, buccal and lingual.

    score 0: no bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant; score 1: isolated bleeding spot visible; score 2: blood forms a confluent red line on margin; score 3: heavy or profuse bleeding. The average of the four scores gives the Modified sulcus bleeding index for the implant

    Measured: Recorded at the 3years follow-up time point

  4. Probing depth

    Measured with a periodontal probe in mm. Normal probing depth is between 1-3mm.

    Measured: Recorded at the 3years follow-up time point

  5. Distance from the implant shoulder to the mucosal margin

    Measured in mm from a 2D radiograph on mesial and distal aspects of the implant

    Measured: Recorded at the 3years follow-up time point

  6. Width of the keratinized mucosa

    Measured with a probe in mm on the buccal surface

    Measured: Recorded at the 3years follow-up time point

  7. Mobility

    Measured by palpation and resonance frequency analysis. Resonance frequency value les than 60 shows low stability and over 70 shows high stability.

    Measured: Recorded at the 3years follow-up time point

  8. Full mouth plaque scores

    Full mouth plaque score expressed as a percentage

    Measured: Recorded at the 3years follow-up time point

  9. Number of participants with intraoperative complications at graft surgery

    Presence or absence of intraoperative complications as assessed by operator. Score 1 : no complications score 2: bleeding The patient is allotted one of the two scores

    Measured: During graft surgery

  10. Number of participants with intraoperative complications at implant surgery

    Presence or absence of intraoperative complications as assessed by operator. Score 1 : no complications score 2: bleeding The patient is allotted one of the two scores

    Measured: During the implant placement surgery

  11. Number of participants with post graft surgery complications

    Presence or absence of post surgical complications as assessed by operator or reported by patient score 1: no complication score 2: hematoma score 3: post operative bleeding score 4: infection score 5: sequestrum The implant is allotted one of the above scores

    Measured: One day after to 6 months post graft surgery

  12. Number of participants with post implant surgery complications

    Presence or absence of post surgical complications as assessed by operator or reported by patient score 1: no complication score 2: hematoma score 3: post operative bleeding score 4: infection score 5: sequestrum The implant is allotted one of the above scores

    Measured: One day after to 6 months post implant surgery

  13. Number of patients with technical complications

    Presence of absence of technical complications with prosthesis as assessed by operator or reported by patient.

    score 1: no complication score 2: chipping score 3: framework fracture score 4:loosening score 5: abutment fracture score 6: new crown to be fabricated The implant is allotted one of the above scores

    Measured: One day after to 3 months post prosthetic rehabilitation

  14. Visual Analog Scale

    As assessed by the patient to rate the experience with the prosthesis on a scale of 1 to 100 with 1 being the lowest and 100 being the highest score

    Measured: 3 years afer implant placement

  15. Oral Health Impact Profile 14

    As assessed by the patient to rate the overall treatment. The patient has to answer 14 questions related to the treatment and each question is scored from a score of 0 to 4.

    score 0: never, score l: hardly ever score 2: occasionally score 3: fairly often, score 4: very often The scores for all questions are added to obtain a score for the patient

    Measured: 3 years after implant placement

Timeline

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

  1. First posted19 Mar 2019
  2. Study start11 Jun 2013
  3. Primary completion7 Dec 2016
  4. Study completion14 May 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
Not applicable
Intervention model
Single group
Model description
A group of thirteen patients were selected for lateral ridge augmentation using cortico-cancellous allogenic block with guided bone regeneration. After the first surgery a healing phase was given and then a second surgery for implant placement in these augmented sites was carried out. Post healing, the implants were prosthetically restored and followed up upto three years.
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03879967
Sponsor's protocol ID
Allo_3_OCS_zmkUnibe
Status last verified
Mar 2019
First submitted
8 Mar 2019
Last updated
19 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chappuis V, Cavusoglu Y, Buser D, von Arx T. Lateral Ridge Augmentation Using Autogenous Block Grafts and Guided Bone Regeneration: A 10-Year Prospective Case Series Study. Clin Implant Dent Relat Res. 2017 Feb;19(1):85-96. doi: 10.1111/cid.12438. Epub 2016 Jul 31.

    PubMed 27476677

Questions about this trial

What is this clinical trial studying?

A study testing Allograft block graft in people with Alveolar Ridge Augmentation, run by University of Bern at 1 site in Switzerland.

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 2 inclusion and 3 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 19 Mar 2019. 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 Switzerland. 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?

Change in ridge thickness with use of the allograft block (time frame: The measurements were done at approximately 9 months after ridge augmentation surgery and prior to implant placement.). 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 NCT03879967, which also lists 1 linked publication.

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 19 Mar 2019; AzTrials last refreshed its copy on 2 Nov 2026.

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