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Dental ImplantsNCT04683991

Increased Peri-implant Keratinized Mucosal Thickness at Different Operative Times

A study testing Subepithelial connective tissue graft in people with Dental Implants and Peri-Implantitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Keratinized mucosa, which is composed of free gingiva and attached gingiva, is a barrier against bacterial invasion in oral cavity and provides good tissue sealing for periodontal environment. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Dental Implants, Peri-Implantitis
What is being tested?
Subepithelial connective tissue graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteChina
Study dates
27 May 2021to 31 Dec 2023
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • No systemic diseases or pregnancy;
  • The thickness of keratinized mucosa where the posterior tooth is missing is less than 2 mm;
  • Full-mouth plaque score (FMPS) < 20% (measured at four sites per tooth) and bleeding on probing score (BOP%) ≤25% (measured at six sites per tooth);
  • Periodontal condition is stable, no probing depths ≥5 mm;
  • No previous soft tissue augmentation procedure at experimental site;
  • The patient has signed informed consent and accepts the operation of subepithelial connective tissue transplantation.

Who cannot join

  • Patients with uncontrolled hypertension;
  • Patients with uncontrolled diabetes;
  • Patients with insufficient oral hygiene and Untreated periodontitis;
  • Pregnant or lactating women;
  • Smoker;
  • Patients with long-term (> 6 months) use of glucocorticoids;
Show all 10Show fewer
  • History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years;
  • Patients with severe cardiovascular problems;
  • Patients with uncontrolled infectious or metabolic diseases;
  • Patients with substance abuse.

Trial locations and contacts

1 site in 1 country.

Weilian Sun, PhD contact

13757119563

weiliansun@zju.edu.cn

China1 site, 1 recruiting
  • Department of Oral Medicine, the Second Affiliated Hospital, School of Medicine Zhejiang University

    Hangzhou, Zhejiang, 310009

    Weilian Sun

    Recruiting

Other trials in China

About this study

Official title: The Effect of Different Surgical Timing on the Clinical Efficacy of Increasing the Thickness of Keratinized Mucosa Around a Single Posterior Implant: a Prospective, Randomized Controlled Clinical Trial

Keratinized mucosa, which is composed of free gingiva and attached gingiva, is a barrier against bacterial invasion in oral cavity and provides good tissue sealing for periodontal environment. When the keratinized mucosa is insufficient, it is difficult to maintain the long-term stability of the implant, which is not conducive to the peri-implant health. It is generally believed that enough keratinized mucosa width is beneficial to reduce plaque accumulation and reduce the incidence rate of peri-implant diseases. In recent years, clinicians have gradually recognized that the thickness of keratinized mucosa plays an important role in maintaining the peri-implant health. Some researchers found that the thickness of mucosa is very important to maintain the aesthetic effect of implant restoration, and when the thickness of mucosa around the implant is less than 2mm, alveolar bone absorption will occur to maintain a stable biological width. A meta-analysis showed that when the thickness of the keratinized mucosa around the implant was greater than 2mm, the amount of marginal bone loss was significantly reduced (- 0.8mm, P < 0.0001).

It is considered that autogenous soft tissue graft is the most reliable technology to augment keratinized mucosa. Subepithelial connective tissue graft (SCTG) is a mucogingival surgery that transplant autologous free connective tissue under the pedicled semi thick flap to augment keratinized mucosa. It can effectively increase the thickness of soft tissue, cover the exposed implant, and reconstruct the interdental papilla. It is the gold standard for peri-implant soft tissue agumentation. Keratinized mucosal thickening surgery may be done prior to the surgical phase, after the surgical phase, before loading, or even after loading. It is believed that keratinized mucosal thickening at the same time of implantation can effectively reduce the possibility of mucosal recession after implantation, reduce the amount of marginal bone absorption in the process of osseointegration, which is conducive to maintaining the long-term stability of the implant. For the sake of clear clinical vision and convenient operation, clinicians often choose to thicken the keratinized mucosa during the secondary operation, and also obtain good postoperative effect. However, after the completion of the final repair, the keratinized mucosa thickening surgery increases the difficulty of operation and the technical requirements for the operator. In clinical practice, it is rarely selected to perform keratinized mucosal thickening at this time. At present, the effectiveness of timing on the outcome of soft tissue augmentation is still debated, and, most importantly, a direct comparison between simultaneous and staged procedures remains underexplored.

Therefore, this clinical trial is to prospectively compare the clinical efficacy of simultaneous versus delayed timing of soft tissue augmentation by SCTG placement around single implants, by evaluating the peri-implant marginal bone level change and soft tissue change, so as to provide reference for the formulation of clinical treatment plan and the selection of the best operation time.

Being tested
Subepithelial connective tissue graft
Keywords
keratinized mucosa thickness, dental Implants, subepithelial connective tissue graft, marginal bone level
Medical subject headings
Peri-Implantitis

What participants receive

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

  • Subepithelial connective tissue graftProcedure or surgery

    A de-epithelialized connective tissue graft is harvested from the homolateral palate and transplanted around the implant.

Study groups in NCT04683991
Study groupRoleWhat they receive
treatment group 1ExperimentalAt the same time of implant implantation, autologous tissue is transplanted into the recipient area by using Subepithelial connective tissue graft.
Receives: Procedure: Subepithelial connective tissue graft
treatment group 2ExperimentalDuring the second stage operation, autologous tissue is transplanted into the recipient area by using Subepithelial connective tissue graft.
Receives: Procedure: Subepithelial connective tissue graft

What is being measured

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

  1. peri-implant marginal bone level change

    The bone level of the proximal and distal sites of the implant is measured by oral X-ray parallel projection method. Compare the image value with the actual value to calculate the actual bone level.

    Measured: 18 months

Secondary outcomes (6)
  1. peri-implant clinical attachment level change

    The distance between the reference point of impression edge and the bottom of gingival groove around the implant.

    Measured: 18 months

  2. peri-implant keratinized mucosa width

    keratinized tissue measured as the distance between muco-gingival junction and the gingival margin.

    Measured: 18 months

  3. peri-implant keratinized mucosa thickness

    gingival thickness measured 1.5 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.

    Measured: 18 months

  4. peri-implant gingival index

    Periodontal probe was used to measure 6 sites on buccal and lingual side each time to observe gingival color, texture and bleeding, and record the scores.

    Measured: 18 months

  5. peri-implant gingival recession

    The distance between the implant shoulder and the gingival margin of the temporary or final crown was measured with a periodontal probe (only when the implant shoulder was visible).

    Measured: 18 months

  6. visual analogue scale

    Visual analogous scale ( VAS) suggested by WHO was used to assess. Analgesia intensity expressed with 0-10, 0 point as without pain completely, 10 points as unbearable pain.

    Measured: 18 months

Timeline

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

  1. First posted24 Dec 2020
  2. Study start27 May 2021
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion31 Dec 2023 (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
Model description
1:1 randomized controlled clinical trial were used. Random numbers generated by SPSS26.0 will be placed in sequentially coded, sealed, opaque envelopes. Only "1" or "0" will be generated, and the number of "1" or "0" generated by SPSS26.0 is 17. When the qualifications of the subjects were determined by the researchers, the envelopes were opened sequentially and the subjects were assigned to groups. The number "1" represented the treatment group 1 and the number "0" represented the treatment group 2.
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04683991
Sponsor's protocol ID
2020-782
Status last verified
Jan 2021
First submitted
22 Dec 2020
Last updated
5 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Subepithelial connective tissue graft in people with Dental Implants and Peri-Implantitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 6 inclusion and 10 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 5 Jan 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. 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 Weilian Sun, PhD (13757119563, weiliansun@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

peri-implant marginal bone level change (time frame: 18 months). 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 5 Jan 2022.

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