Evaluation of implant stability in head and neck cancer patients.
- Conditions
- Malignant neoplasm of lower gum,
- Registration Number
- CTRI/2018/08/015521
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
A study is planned to assess the stability of osseointegrated dental implant which has been under prosthetic functional loading in head and neck cancer patients.
Aims: assess implant stability after minimum of 6 months of prosthetic loading and at follow-up after 6 months.
Primary objective: to assess implant stability after completion of minimum of 6 months since prosthetic rehabilitation and at next follow up after 6 months.
Secondary objective: i. to compare implant stability in native bone and fibula reconstructed jaw. ii. to compare implant stability in irradiated and non irradiated subjects after prosthetic loading. iii. to assess crestal bone loss after loading of implant.
Consenting patients who fulfill inclusion and exclusion criteria will be taken up for the study after ethics committee approval. All these patients will have received dental implant rehabilitation and completed a minimum of 6 months of prosthetic loading. The Periotest device will be used to evaluate the implant stability after a minimum of 6 months of prosthetic loading stage and after 6 months at follow up visits. Periotest is a device designed to evaluate mobility of implant by detecting the damping capacity of surrounding bone. It consists of a tapping metal slug. Periotest requires the time required for the tapping metal slug to make contact with an implant using an accelerometer. It can detect bone resorption and reflects the degree of bone implant contact.
Recording Periotest values: the measurement of implant stability with Periotest will be done by a single operator. The patient will be seated on a dental chair, with his/her back straight such that the mandible is parallel to the floor. The implant abutment seen in the patients mouth should be at right angles to the floor. The Periotest device will be held by the operator so that it is parallel to the floor and the percussing tip is just away from the implant abutment. Three readings will be recorded for the Periotest values and average of the readings will be taken into account. Panaromic radiographs OPG and intra oral periapical radiographs will be taken as standard protocol for all patients.
Assessment of crestal bone loss: An intra oral periapical radiograph with intraoral x-ray grid will be recorded. This grid in the radiograph will enable measurement of bone levels surrounding the crest of the dental implants.
Evaluation and assessment: first assessment will be done at the time of follow-up of minimum 6 months after loading of the implants (prosthetic rehabilitation). Second assessment will be done again after 6 months at followup. Variables to be studied are: i) Periotest values ii) Radiographic assessment of crestal bone loss if any after loading of dental implants.
Analysis of variables: data will be presented as mean, median (range) and frequency. Continuous variables will be analyzed using independant t test or Mann Whitney test as per distribution. Categorical data will be analysed using Chi-square test or Fisher Exact tesr (for binary data). Paired comparison will be done using Paired t tesr/Wilcoxon signed rank test as per the distribution. Repeated measures ANOVA will be used to compare data at different time points. Data will analyzed using descriptive statistic using IBM SPSS 24.0 (Armonk, NY). P - value < 0.05 will be considered statistically significant.
50 patients were recruited in the study, of which 40 were males and 10 were females.The age ranged from 18 – 76 years with a mean of 55.55 years.Dental implants were placed in the free fibula flap in 24 patients and in native jaw in 26 patients.In the native jaw, dental implants were placed in 13 maxilla and 41mandibles.With respect to radiation, 37 patients were radiated and 13 patients not radiated. 34 patients had a habit of usage of some form of tobacco (smoking, chewing, paan with arecanut, khaini and masheri).
Most of the patients registered PTV ranging from -8 to 0.This suggests optimum osseointegration after prosthetic loading of the implants.There was imperceptible change overtime between the PTV at follow-up.The outcome of the comparision within the groups at the two time points was not significant. A comparison of the PTV with respect to time i.e. at 6 months and 12 month follow-up showed a similar result (p > 0.05).
5 patients recorded PTV more than +10 which mean insufficient osseointegration.Of the 5 patients 3 showed worsening of the PTV and 2 showed improvement overtime at the follow up readings, though the PTV was more than +8 after improvement. Of the 50 patients 1 dental implant was lost in 1 patient, 1 was submerged in 1 and 1 patient developed recurrence around an implant during the study period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
-
- Consenting patients with head and neck carcinoma who have undergone dental implant rehabilitation.
-
- Patients who have completed 6 months since implant retained prosthetic rehabilitation.
-
- Patients below the age of 18 years.
-
- Patients who have recurrences.
-
- Implants which cannot be loaded due to various reasons (buccal placement of implant, implant submerged under the submucosa, tilted implants not amenable to prosthetic loading).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess implant stability after completion of minimum of 6 months since prosthetic rehabilitation and at the next follow up after 6 months 6 months after prosthetic rehabilitation and at the next follow up after 6 months
- Secondary Outcome Measures
Name Time Method i.To compare implant stability in native bone and fibula reconstructed jaw. ii.To compare implant stability in irradiated and non-irradiated subjects after prosthetic loading of implant.
Trial Locations
- Locations (1)
217, Second floor,Dept of Dental and Prosthetic Surgery, Homi Bhaba Block
🇮🇳Mumbai, MAHARASHTRA, India
217, Second floor,Dept of Dental and Prosthetic Surgery, Homi Bhaba Block🇮🇳Mumbai, MAHARASHTRA, IndiaDr K P DholamPrincipal investigator02224177224kdholam@hotmail.com