Clinical trial NCT06475313: Risk Assessment of Proximal Contact Loss Between Implant-supported Prostheses and Adjacent Teeth.
Official title: Risk Assessment of Proximal Contact Loss Between Implant-supported Prostheses and Adjacent Teeth.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Peri-Implantitis and Peri-implant Mucositis
Keywords: food impaction
proximal contact loss
Implant supported prosthesis
Dentition defect
risk factors
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* (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.

Exclusion Criteria:

* (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.

Primary outcomes:
measure: the proximal contact surface was adjusted by a dental floss (Reach waxed dental floss from Johnson & Johnson, standard thickness)
timeFrame: Patients with implant-supported prostheses reviewed 3 months after delivery were eligible for inclusion in this study.
Secondary outcomes:
measure: oral panoramic radiograph
timeFrame: Patients with implant-supported prostheses reviewed 3 months after delivery were eligible for inclusion in this study.
measure: Bausch Arti-Fol R metallic Shimstock-Film
timeFrame: Patients with implant-supported prostheses reviewed 3 months after delivery were eligible for inclusion in this study.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Changao Xue, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Ning Luo, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Juan Lin, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.