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Tooth FractureNCT05127629

Comparison of Clinical Outcomes of Different Wound Closure Methods in Immediate Implant Placement in the Aesthetic Zone

A study testing Immediate implant placement, Guided bone regeneration and Wound closure with gelatin sponge in people with Tooth Fracture and Tooth Decay, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Implant-supported restorations have become one of the best treatment options for patients with tooth loss, with predictable long-term success rates and clinical outcomes. Immediate implant placement means the implant is placed immediately after tooth extraction. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tooth Fracture, Tooth Decay
What is being tested?
Immediate implant placement, Guided bone regeneration and Wound closure with gelatin sponge
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteChina
Study dates
1 Apr 2021to Dec 2022
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 who are at least 18 years old and in good health;
  • Single tooth in the maxillary anterior aesthetic area to be extracted for immediate implant placement;
  • The labial bone plate is intact and there is sufficient bone in the apical region to ensure initial stability.
  • Healthy intraoral soft tissues and no infection.

Who cannot join

  • Need to place more than 1 implant in the aesthetic area.
  • Heavy smokers (> 10 cigarettes/day).
  • Patients with physical diseases such as: uncontrolled diabetes (fasting glucose > 7.2 mmol/L, glycosylated hemoglobin > 7%), current intake of bisphosphonate medication, history of head and neck malignancy, history of head and neck radiotherapy, pregnancy or preparation for pregnancy, etc.
  • Patients with uncontrolled periodontitis and unstable periodontal status.
  • Lateral labial bone plate defect;
  • Missing teeth;
  • Allergic to titanium;
  • Those who do not wish to participate in this study.

Trial locations and contacts

1 site in 1 country.

Beilei Liu, Doctor contact

13061800982

beilei_liu@outlook.com

China1 site, 1 recruiting
  • Department of Oral and Maxillofacial Implantology

    Shanghai, Shanghai Municipality, 200011

    Jun-Yu Shi, MDS, 23271073

    Recruiting

Other trials in China

About this study

Implant-supported restorations have become one of the best treatment options for patients with tooth loss, with predictable long-term success rates and clinical outcomes. Immediate implant placement means the implant is placed immediately after tooth extraction. It can significantly reduce treatment time because extraction socket healing and implant osseointegration occur simultaneously. Immediate implant placement has many benefits, reducing the overall treatment time, reducing the patient's surgical procedures, and reducing surgical trauma (no flap reversal). However, the treatment also has significant limitations, including the inability to predict the possibility of bone and soft tissue healing, and the possibility of subsequent unfavorable esthetic outcomes. However, the evidence regarding soft and hard tissue and aesthetic outcomes in patients treated with immediate implants in the aesthetic area remains inconclusive. As the aesthetic success of implant restorations is increasingly valued over implant survival, there are significant clinical benefits to addressing immediate implant bone tissue resorption and soft tissue deficiencies and improving the aesthetic outcome of immediate implant restorations.

To address the potential health and aesthetic problems associated with soft and hard tissue deficiencies around dental implants, bone grafting in the jumping gap and soft tissue grafting procedures are often performed. According to literature, autologous soft tissue grafts have shown the best clinical and histological results in soft tissue regeneration techniques. However, it requires removal of tissue from the patient's donor area, which can add additional trauma. In contrast, gelatin sponges, currently commonly used as wound closure materials, are only hemostatic and rapidly absorbed postoperatively, and do not provide protection of hard and soft tissue augmentation. Collagen matrix has recently been introduced for keratinized gingival augmentation and has shown encouraging results in preclinical and clinical studies, but more information is needed to confirm its clinical efficacy. Mucograft® Seal is a porcine collagen matrix with a bilayer structure, a dense and slowly absorbing layer and a spongy layer that stabilizes blood clots and allows soft tissue cells to penetrate. Human gingival fibroblasts cultured on Mucograft® were demonstrated to have good proliferative properties and cell viability as scaffold material. In dog extraction sites, preliminary results suggest that the combination of Mucograft® and Bio-Oss Collagen may be an effective method for alveolar ridge preservation. Mucograft® Seal can be used in combination with Bio-Oss Collagen® for alveolar ridge preservation after tooth extraction.

Read more

The research hypothesis is that the use of a collagen matrix to seal the wound in immediate implant placement in aesthetic area will reduce buccal bone resorption and increase the width and thickness of the soft tissue at the implant site.

Therefore, we designed this comparative clinical trial in which patients accept immediate implant placement in aesthetic area. The implant is placed after tooth extraction, and bone graft material Bio-Oss Collagen® is placed in the jump gap, and the wound was closed by different means (collagen matrix or gelatin sponge randomly). The clinical examination, CBCT imaging and histological evaluations were performed to compare the differences in clinical efficacy of the two wound closure methods. The primary outcome is the buccal bone thickness change at the immediate implant site 4 months after surgery.

Being tested
Immediate implant placement, Guided bone regeneration, Wound closure with gelatin sponge, Wound closure with collagen matrix
Keywords
Immediate implant placement
Medical subject headings
Tooth Fractures, Dental Caries

What participants receive

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

  • Immediate implant placementProcedure or surgery

    After tooth extraction, a dental implant is placed immediately.

  • Guided bone regenerationProcedure or surgery

    After implant placement, the gap between implant and the buccal bone wall is filled with Bio-oss collagen.

  • Wound closure with gelatin spongeProcedure or surgery

    After guided bone regeneration, patient in the control group receive gelatin sponge for wound closure.

  • Wound closure with collagen matrixProcedure or surgery

    After guided bone regeneration, patient in the control group receive collagen matrix (Mucograft Seal) for wound closure.

Study groups in NCT05127629
Study groupRoleWhat they receive
ControlPlacebo comparatorNot described
Receives: Procedure: Immediate implant placement; Procedure: Guided bone regeneration; Procedure: Wound closure with gelatin sponge
Collagen matrixExperimentalNot described
Receives: Procedure: Immediate implant placement; Procedure: Guided bone regeneration; Procedure: Wound closure with collagen matrix

What is being measured

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

  1. Thickness of the buccal bone

    Change in labial alveolar bone thickness, including alveolar bone thickness and implant bone powder thickness

    Measured: 4 months after implant surgery

Secondary outcomes (3)
  1. gingival thickness

    Change of gingival thickness

    Measured: 4 months after implant surgery

  2. success rate

    success rate of implant

    Measured: 4 months after implant surgery

  3. Wound healing

    Wound healing status

    Measured: 2weeks and 4 months after implant surgery

Timeline

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

  1. First posted19 Nov 2021
  2. Study start1 Apr 2021
  3. Primary completionSep 2022 (estimated)
  4. Study completionDec 2022 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05127629
Sponsor's protocol ID
20210205.V1
Status last verified
Mar 2022
First submitted
9 Nov 2021
Last updated
31 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: ngc

Questions about this trial

What is this clinical trial studying?

A study testing Immediate implant placement, Guided bone regeneration and Wound closure with gelatin sponge in people with Tooth Fracture and Tooth Decay, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 4 inclusion and 8 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 31 Mar 2022. 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?

Results are not available in the source record.

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

Contact Beilei Liu, Doctor (13061800982, beilei_liu@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Thickness of the buccal bone (time frame: 4 months after implant surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 31 Mar 2022.

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