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Peri-Implantitis and Peri-implant MucositisNCT06475313

Risk Assessment of Proximal Contact Loss Between Implant-supported Prostheses and Adjacent Teeth.

An observational study of Peri-Implantitis and Peri-implant Mucositis, run by Nanjing First Hospital, Nanjing Medical 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 The sponsor has not verified this record for over two years, so it may be out of date.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

In this study, we collected and analysed the review results of 100 patients over 18 years of age who received implant fixed restorations in the Department of Stomatology of the First Hospital of Nanjing, China. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
plaque index assessment, periodontal probing, Bleeding on probing (BOP), Prosthetic adjacency check, initial occlusal contact, maximum occlusal contact, and filling of the cusps.
How many people
100 participants
Where
1 siteChina
Study dates
1 Jul 2024to 30 Dec 2024
Phase
Observational
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: One hundred consecutive patients, who had received either implant-supported fixed partial denture (FPD) or implant-supported single crown (SC) in the posterior region and were under regular review, were recruited.

Who may be able to join

  • (1) Patients over the age of 18, can fully understand the nature of the proposed and be able to sign a consent form.
  • (2) patients who underwent dental implant surgery and delivered prostheses for more than 3 months in Nanjing First Hospital.

Who cannot join

  • (1) The implant site or adjacent teeth were severely injured and the adjacent teeth were extracted;
  • (2) the same quadrant orthodontic or splint treatment;
  • (3) the prostheses have been removed due to failure or need further treatment;
  • (4) implant-supported prostheses in both mesial and distal sites;
  • (5) the adjacent teeth were directly or indirectly fixed with the implant-supported prosthesis;
  • (6) patients with missing clinical records of PD, PCR and BOP.
  • (7) The prosthetic prosthesis with implant-supported prosthesis was delivered for less than 3 months in Nanjing First Hospital.

Trial locations and contacts

1 site in 1 country.

Xin Wu, Master contact

13770326060

darkie777@163.com

Jiaping Wang contact

15563518685

wjpsally@stu.njmu.edu.cn

China1 site

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210000

    Xin Wu, master, 13770326060, darkie777@163.com

    Jiaping Wang, 15563518685, wjpsally@stu.njmu.edu.cn

Other trials in China

About this study

In this study, we collected and analysed the review results of 100 patients over 18 years of age who received implant fixed restorations in the Department of Stomatology of the First Hospital of Nanjing, China. The aim was to investigate the incidence of loss of contact between implant restorations and adjacent teeth and its influencing factors. Our findings may provide better insights for treatment planning and prevention of PCL.

Read the detailed description

Food impaction is a common complication after implant-supported restorations. Several studies have reported that more than 40%-66.9% of patients feel food impaction between the implant restoration and adjacent natural teeth. The most common cause of food impaction after implant restoration is the proximal contact loss(PCL), which has been reported to occur in 34% to 65% of cases. The location of PCL creates discomfort and leads to gingival inflammation and even peri-implant bone resorption, which ultimately leads to loosening of the implant. In our long-term clinical observation, not all final restorations suffer from PCL. The occurrence of PCL may be related to a number of factors such as age, gender, functional time, and so on. However, the literature addressing this issue is still limited. In this study, we collected and analysed the review results of selected patients who underwent implant-supported restorations in the First Hospital of Nanjing, China, to investigate the incidence of PCL between the implant restorations and the adjacent teeth adjacent , and the factors influencing it. Our findings may provide better insights for treatment planning and prevention of PCL.

Being tested
plaque index assessment, periodontal probing, Bleeding on probing (BOP), Prosthetic adjacency check, initial occlusal contact, maximum occlusal contact, and filling of the cusps.
Keywords
food impaction, proximal contact loss, Implant supported prosthesis, Dentition defect, risk factors
Medical subject headings
Peri-Implantitis

What participants receive

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

  • plaque index assessment, periodontal probing, Bleeding on probing (BOP), Prosthetic adjacency check, initial occlusal contact, maximum occlusal contact, and filling of the cusps.Behavioural

    Also called Radiation

    oral panoramic radiograph

What is being measured

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

  1. the proximal contact surface was adjusted by a dental floss (Reach waxed dental floss from Johnson & Johnson, standard thickness)

    The degree of proximal contact loss(PCL) was evaluated with a dental floss passing through the contact areas and classified as: (a) tight: sufficient resistance to the passage of the floss; (b) loose: insufficient resistance to the passage of the floss; and (c) open: contact: no resistance to the passage of the floss. The presence of an open or loose contact was classified as PCL.

    Measured: Patients with implant-supported prostheses reviewed 3 months after delivery were eligible for inclusion in this study.

Secondary outcomes (2)

  1. oral panoramic radiograph

    Using the radiograph analysis software's measuring function, the amount of alveolar bone resorption of the implant as well as adjacent teeth was evaluated. (a)The original bone height was measured as the distance between the enamel-cemental junction and the root apex (or the implant neck edge and the implant base). (b)The existing bone height was measured as the distance between the top of the alveolar ridge to the root apex. (c) The height of alveolar bone resorption was calculated by subtracting the original bone height from the existing bone height.

    Measured: Patients with implant-supported prostheses reviewed 3 months after delivery were eligible for inclusion in this study.

  2. Bausch Arti-Fol R metallic Shimstock-Film

    (a) Initial occlusal contact: Bausch articulating paper was applied to the restoration's occlusal surface, the patient was told to close their mouth slowly, the teeth just gently touched, and they opened their mouth right away. The paper was then removed, and the restoration's occlusal surface was examined to see if it had left a red mark. (b) Final occlusal contact: If the patient's restoration and opposing jaw teeth do not make contact during the initial occlusion, place the Bausch articulating paper on the restoration's occlusal surface, ask them to clench their teeth, and then have them open their mouth, take the paper out, and check to see if the implant's occlusal surface has any marks on it.

    Measured: Patients with implant-supported prostheses reviewed 3 months after delivery were eligible for inclusion in this study.

Timeline

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

  1. First posted26 Jun 2024
  2. Study start1 Jul 2024 (estimated)
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06475313
Sponsor's protocol ID
KY20240613-05
Status last verified
Jun 2024
First submitted
20 Jun 2024
Last updated
26 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Information about participants in this study will not be shared with investigators outside the study, and all study participants are identified by initials.

Publications

  • Yen JY, Kang L, Chou IC, Lai YL, Lee SY. Risk assessment of interproximal contact loss between implant-supported fixed prostheses and adjacent teeth: A retrospective radiographic study. J Prosthet Dent. 2022 Jan;127(1):86-92. doi: 10.1016/j.prosdent.2020.06.023. Epub 2020 Nov 7.

    PubMed 33172648

  • Bompolaki D, Edmondson SA, Katancik JA. Interproximal contact loss between implant-supported restorations and adjacent natural teeth: A retrospective cross-sectional study of 83 restorations with an up to 10-year follow-up. J Prosthet Dent. 2022 Mar;127(3):418-424. doi: 10.1016/j.prosdent.2020.09.034. Epub 2020 Dec 17.

    PubMed 33342612

  • Liang CH, Nien CY, Chen YL, Hsu KW. The prevalence and associated factors of proximal contact loss between implant restoration and adjacent tooth after function: A retrospective study. Clin Implant Dent Relat Res. 2020 Jun;22(3):351-358. doi: 10.1111/cid.12918. Epub 2020 May 17.

    PubMed 32419242

  • Gasser TJW, Papageorgiou SN, Eliades T, Hammerle CHF, Thoma DS. Interproximal contact loss at implant sites: a retrospective clinical study with a 10-year follow-up. Clin Oral Implants Res. 2022 May;33(5):482-491. doi: 10.1111/clr.13908. Epub 2022 Mar 1.

    PubMed 35194854

Questions about this trial

What is this clinical trial studying?

An observational study of Peri-Implantitis and Peri-implant Mucositis, run by Nanjing First Hospital, Nanjing 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 2 inclusion and 7 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 26 Jun 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. 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 Xin Wu, Master (13770326060, darkie777@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the proximal contact surface was adjusted by a dental floss (Reach waxed dental floss from Johnson & Johnson, standard thickness) (time frame: Patients with implant-supported prostheses reviewed 3 months after delivery were eligible for inclusion in this study.). 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 NCT06475313, which also lists 4 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 26 Jun 2024.

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