Comparative evaluation of crestal bone loss levels around dental implants placed in thick and thin mucosal tissues - a clinicoradiographic study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- More crestal bone loss around the implants placed in thin mucosal tissue.
Study Overview
Brief Summary
i) Rationale:
Peri-implantitis can be defined as a crestal bone loss / marginal bone loss (MBL) equal to or greater than three millimeters in the presence of clinical signs such as PPD > 6 mm and BOP.Although MBL does not always lead to peri-implantitis, there is no peri-implantitis without the prior presence of MBL. Berglundh et al. has related this to thickness of soft tissues. They reported that in thin tissues formation of gingival cuff after the second stage surgery resulted in significant bone resorption, in contrast to the thick tissue group, where no statistically reliable bone loss occurred. Hence, it seems that correlation between the thickness of gingival tissue and subsequent bone loss around implants does exist.
ii) Novelty:
Assesment in mucosal tissue thickness classification given by Egreja et al in 2012. Marginal bone loss will be measured using CBCT in SIDEXIS 4 software with SICATSUITE version 2.0. (Dentsp ly Sirona; York, US) immediately after implant placement and 6 months later.
iii) Objectives:
To evaluate and compare the MBL around the implants placed in thin and thick mucosal tissue.
iv) Methods:
The mucosal tissue thickness will be assessed with transgingival probing method given by Dimitrios Kloukos et al in 2021.Radiographic assessments for MBL around the implant will be done immediately after implant placement, 6 months and 12 months later using CBCT. MBL will be measured using SIDEXIS 4 software with SICATSUITE version 2.0. (Dentsply Sirona; York, US)
v) Expected outcome:
Less marginal bone loss in thick mucosal tissue as compared to thin mucosal tissue.
Hypothesis:
In thin and thick mucosal tissue there might be marginal bone loss or no marginal bone loss around the implant
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Eighteen years of age to sixty five years of age.
- •Fully healed bone sites.
- •(at least 6 months after tooth extraction)
- •No bone augmentation procedures before and during implant placement.
- •Edentulous gap for at least 1 implant in any region of the mouth with minimum 1mm distance range from adjacent tooth/teeth.
- •No medical contraindication for implant surgery.
- •Edentulous site of implant in any region of the mouth with minimum 1mm of mucosal tissue thickness.
Exclusion Criteria
- •Poor oral hygiene.
- •Symptoms or history of periodontitis or peri-implantitis treatment.
- •Smoker and alcoholic person.
- •Patients with systemic diseases.
- •Alveolar ridges with bone defects at implantation sites.
- •Attached gingiva ≤ 2 mm.
Outcomes
Primary Outcomes
More crestal bone loss around the implants placed in thin mucosal tissue.
Time Frame: crestal bone loss will be checked around the implants after 6 months and 12 months of implant placement with CBCT
Secondary Outcomes
- Less crestal bone loss around the implants placed in thick mucosal tissue.(crestal bone loss will be checked around the implants after 6 months and 12 months of implant placement with CBCT)
Investigators
Dr Bhutada Chetan Gopal
Coorg Institute Of Dental Sciences