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Dental ImplantationNCT06574815

Effects of the SIS Membrane on GBR and Early Loading of Maxillary Anterior Dental Implants

A study testing Early implant loading, Delayed implant loading and GBR using an SIS membrane in people with Dental Implantation and Guided Bone Regeneration, run by Beijing Stomatological Hospital, Capital Medical University at 1 site in China.

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

The aim of this randomized controlled trial (RCT) is to determine whether early implant loading that shortens the healing period to 6 weeks can be safely and effectively applied to implants with good initial stability in the maxillary anterior region, which undergoes simultaneous guided bone regeneration (GBR), via… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dental Implantation, Guided Bone Regeneration
What is being tested?
Early implant loading, Delayed implant loading and GBR using an SIS membrane
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteChina
Study dates
30 Apr 2023to 16 Aug 2024
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients with single maxillary anterior tooth loss (sites: 12, 11, 21, 22);
  • age ≥18 years;
  • sex not limited;
  • no history of systemic diseases such as heart disease, hypertension, or diabetes;
  • no periodontal disease or already received periodontal systemic treatment;
  • cone-beam computed tomography (CBCT) revealed that the thickness of the alveolar ridge in the tooth loss area was greater than 3 mm but less than 5 mm;
  • using hydrophilic-modified sandblasted and acid-etched (SLActive) bone level tapered (BLT) dental implant systems.

Who cannot join

  • patients receiving radiotherapy and chemotherapy;
  • patients with a history of hepatitis, tuberculosis, or other infectious diseases;
  • patients with very poor oral hygiene;
  • patients who were heavy smokers;
  • pregnant women.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Stomatological Hospital, Capital Medical University

    Beijing

Other trials in China

About this study

Official title: Evaluation of the Effects of the Small Intestine Submucosa (SIS) Biological Membrane on Guided Bone Regeneration (GBR) and Early Loading of Dental Implants in the Maxillary Anterior Region

The aim of this randomized controlled trial (RCT) is to determine whether early implant loading that shortens the healing period to 6 weeks can be safely and effectively applied to implants with good initial stability in the maxillary anterior region, which undergoes simultaneous guided bone regeneration (GBR), via clinical examination, intraoral scanning, imageological diagnosis, and aesthetic scoring, and to determine the clinical effect of the small intestine submucosa (SIS) biological barrier membrane in such cases involving early loading. This study is expected to provide preliminary guidance on the timing of loading for a single maxillary anterior implant with insufficient bone volume and provide a theoretical basis for the selection of a biological barrier membrane for GBR in such patients.

Read the detailed description

Patients were randomized into three groups at a 1:1:1 ratio, including the GBR with a Bio-Gide membrane and delayed implant loading (Gide-DL) group, the GBR with a Bio-Gide membrane and early implant loading (Gide-EL) group, and the GBR with an SIS membrane and early implant loading (SIS-EL) group. The allocation sequence was generated through an online tool (www. random.org) and was concealed in sealed envelopes. At 6 weeks after implant and GBR surgery, the implant stability quotient (ISQ) was measured and recorded at the labial, palatal, mesial, and distal locations via the Osstell device in the Gide-EL group and the SIS-EL group. If the ISQ was ≥ 65, definitive restoration (early loading) was performed (if < 65, the subject was withdrawn from the trial). The digital impressions and occlusal relationships were obtained via intraoral scanning, and the implant-supported crown was designed based on the digital model. Titanium base abutments with angled screw channels (ASCs) and porcelain veneered zirconia (PVZ) crowns were used for restoration. Immediately after definitive restoration, intraoral scanning was used to record the soft tissue contour at the implant site, and CBCT was used to examine the bone tissue around the implant. In addition, patients in the Gide-DL group underwent definitive restoration at 6 months after surgery (delayed loading), and the treatment process was the same as that in the Gide-EL and SIS-EL groups at 6 weeks after surgery. Clinical examination, intraoral scanning, imageological diagnosis, and aesthetic scoring were used to determine the clinical effect of SIS membranes and early implant loading at 1-year follow-up.

Being tested
Early implant loading, Delayed implant loading, GBR using an SIS membrane, GBR using an Bio-Gide membrane
Keywords
Dental implantation, Guided bone regeneration, Early loading, Small intestine submucosa membranes, Randomized controlled trial

What participants receive

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

  • Early implant loadingProcedure or surgery

    Patients underwent definitive restoration at 6 weeks after implant surgery (early loading).

  • Delayed implant loadingProcedure or surgery

    Patients underwent definitive restoration at 6 months after implant surgery (delayed loading).

  • GBR using an SIS membraneProcedure or surgery

    An small intestine submucosa (SIS) membrane was used in the guided bone regeneration (GBR) surgery.

  • GBR using an Bio-Gide membraneProcedure or surgery

    An Bio-Gide membrane was used in the guided bone regeneration (GBR) surgery.

Study groups in NCT06574815
Study groupRoleWhat they receive
SIS-ELExperimentalGuided bone regeneration (GBR) with an SIS membrane and early implant loading
Receives: Procedure: Early implant loading; Procedure: GBR using an SIS membrane
Gide-ELActive comparatorGuided bone regeneration (GBR) with a Bio-Gide membrane and early implant loading
Receives: Procedure: Early implant loading; Procedure: GBR using an Bio-Gide membrane
Gide-DLSham comparatorGuided bone regeneration (GBR) with a Bio-Gide membrane and delayed implant loading
Receives: Procedure: Delayed implant loading; Procedure: GBR using an Bio-Gide membrane

What is being measured

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

  1. Soft tissue contour assessment

    Intraoral scanning was used to collect the soft tissue contour at the implant site, the contour of the implant-supported crown and adjacent natural teeth. The preoperative, immediate postoperative, and 1-year follow-up intraoral scanning data in stereolithography (STL) formats were imported into Exocad 3.0 software. The best-fit images of the median sagittal section at the implant site were extracted, and the horizontal contour changes (HCCs) were measured at 1 mm and 3 mm below the crown-gingiva margin. The preoperative contour was used as the baseline to detect the immediate postoperative horizontal contour increase (HCI), and the immediate postoperative contour was used as another baseline to detect the 1-year follow-up horizontal contour decrease (HCD).

    Measured: At the 1-year follow-up

  2. Marginal bone level assessment

    X-ray images immediately postoperative (baseline) and at the 1-year follow-up were taken, and the distances from the most coronal bone-to-implant or bone-to-superstructure contact point to the reference point (neck margin of the implant) were measured at the mesial and distal sides of the implant; then, the data were averaged. Negative values were recorded when the contact point was at the root side of the reference point, and positive values were recorded when the contact point was at the crown side of the reference point. The data were calibrated with the known length of the implant to correct for distortion. The MBL changes were obtained by subtracting the baseline data from the 1-year follow-up data.

    Measured: At the 1-year follow-up

Timeline

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

  1. First posted28 Aug 2024
  2. Study start30 Apr 2023
  3. Primary completion2 Aug 2024
  4. Study completion16 Aug 2024

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
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06574815
Sponsor's protocol ID
CMUSH-IRB-KJ-PJ-2023-24
Other IDs
CSA-SIS2022-17
Status last verified
Aug 2024
First submitted
26 Aug 2024
Last updated
30 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu R, Yang Z, Tan J, Chen L, Liu H, Yang J. Immediate implant placement for a single anterior maxillary tooth with a facial bone wall defect: A prospective clinical study with a one-year follow-up period. Clin Implant Dent Relat Res. 2019 Dec;21(6):1164-1174. doi: 10.1111/cid.12854. Epub 2019 Nov 11.

    PubMed 31709704

  • Benic GI, Ge Y, Gallucci GO, Jung RE, Schneider D, Hammerle CH. Guided bone regeneration and abutment connection augment the buccal soft tissue contour: 3-year results of a prospective comparative clinical study. Clin Oral Implants Res. 2017 Feb;28(2):219-225. doi: 10.1111/clr.12786. Epub 2016 Feb 8.

    PubMed 26856399

  • Pirc M, Harbeck O, Sapata VM, Husler J, Jung RE, Hammerle CHF, Thoma DS. Contour changes of peri-implant tissues are minimal and similar for a one- and a two-piece implant system over 12 years. Clin Oral Investig. 2021 Feb;25(2):719-727. doi: 10.1007/s00784-020-03638-1. Epub 2020 Oct 15.

    PubMed 33063219

  • Liu Z, Yu X, Ma B, Yang Y, Mu Y, Lu X, Li M, Jing W, Wei P, Ma S, Zhao B, Deng J. SIS membrane modification to improve antimicrobial and osteogenic properties for guide bone regeneration. J Biomater Sci Polym Ed. 2023 Aug;34(10):1337-1359. doi: 10.1080/09205063.2023.2166337. Epub 2023 Jan 17.

    PubMed 36607605

  • Liu Z, Wei P, Cui Q, Mu Y, Zhao Y, Deng J, Zhi M, Wu Y, Jing W, Liu X, Zhao J, Zhao B. Guided bone regeneration with extracellular matrix scaffold of small intestinal submucosa membrane. J Biomater Appl. 2022 Nov;37(5):805-813. doi: 10.1177/08853282221114450. Epub 2022 Aug 4.

    PubMed 35924456

  • Qian SJ, Pu YP, Zhang XM, Wu XY, Liu BL, Lai HC, Shi JY. Clinical, radiographic, and esthetic evaluation of immediate implant placement with buccal bone dehiscence in the anterior maxilla: A 1-year prospective case series. Clin Implant Dent Relat Res. 2023 Feb;25(1):3-10. doi: 10.1111/cid.13154. Epub 2022 Nov 14.

    PubMed 36373737

  • Cairo F, Nieri M, Cavalcanti R, Landi L, Rupe A, Sforza NM, Pace R, Barbato L. Marginal soft tissue recession after lateral guided bone regeneration at implant site: A long-term study with at least 5 years of loading. Clin Oral Implants Res. 2020 Nov;31(11):1116-1124. doi: 10.1111/clr.13658. Epub 2020 Sep 23.

    PubMed 32875633

  • Dard M, Shiota M, Sanda M, Yajima Y, Sekine H, Kasugai S. A randomized, 12-month controlled trial to evaluate non-inferiority of early compared to conventional loading of modSLA implants in single tooth gaps. Int J Implant Dent. 2016 Dec;2(1):10. doi: 10.1186/s40729-016-0040-8. Epub 2016 Apr 4.

    PubMed 27747702

  • Alshhrani WM, Al Amri MD. Customized CAD-CAM healing abutment for delayed loaded implants. J Prosthet Dent. 2016 Aug;116(2):176-9. doi: 10.1016/j.prosdent.2016.01.024. Epub 2016 Mar 30.

    PubMed 27038526

  • Gan LM, Zhou QR, Zhang Y, Yu YC, Yu ZZ, Sun Y, Li RX, Wu XW, Yang F. Alveolar Bone Morphologic Predictors for Guided Bone Regeneration Outcome in Anterior Maxilla. Int Dent J. 2024 Feb;74(1):102-109. doi: 10.1016/j.identj.2023.07.007. Epub 2023 Sep 14.

    PubMed 37714716

  • ElAskary A, Elfana A, Meabed M, Abd-ElWahab Radi I, Akram M, Fawzy El-Sayed K. Immediate implant placement utilizing vestibular socket therapy versus early implant placement with contour augmentation for rehabilitation of compromised extraction sockets in the esthetic zone: A randomized controlled clinical trial. Clin Implant Dent Relat Res. 2022 Oct;24(5):559-568. doi: 10.1111/cid.13120. Epub 2022 Jul 10.

    PubMed 35811090

  • Zuercher AN, Strauss FJ, Paque PN, Bienz SP, Jung RE, Thoma DS. Randomized controlled pilot study comparing small buccal defects around dental implants treated with a subepithelial connective tissue graft or with guided bone regeneration. Clin Oral Implants Res. 2023 Oct;34(10):1094-1105. doi: 10.1111/clr.14140. Epub 2023 Jul 23.

    PubMed 37483129

  • Basler T, Naenni N, Schneider D, Hammerle CHF, Jung RE, Thoma DS. Randomized controlled clinical study assessing two membranes for guided bone regeneration of peri-implant bone defects: 3-year results. Clin Oral Implants Res. 2018 May;29(5):499-507. doi: 10.1111/clr.13147. Epub 2018 Apr 15.

    PubMed 29656495

  • Naenni N, Stucki L, Husler J, Schneider D, Hammerle CHF, Jung RE, Thoma DS. Implants sites with concomitant bone regeneration using a resorbable or non-resorbable membrane result in stable marginal bone levels and similar profilometric outcomes over 5 years. Clin Oral Implants Res. 2021 Aug;32(8):893-904. doi: 10.1111/clr.13764. Epub 2021 Jun 4.

    PubMed 33977571

Questions about this trial

What is this clinical trial studying?

A study testing Early implant loading, Delayed implant loading and GBR using an SIS membrane in people with Dental Implantation and Guided Bone Regeneration, run by Beijing Stomatological Hospital, Capital Medical University at 1 site in China.

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 30 Aug 2024. 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 China. 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. Some participants in this study may receive a placebo. 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?

Soft tissue contour assessment (time frame: At the 1-year follow-up). 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 NCT06574815, which also lists 14 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 30 Aug 2024.

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