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Clinical Trials/NCT07001813
NCT07001813CompletedNot Applicable

Clinical and Radiographic Assessment of the Outcomes of Dental Implant Inserted After Xenograft Socket Preservation in Posterior Maxilla: A Randomized Controlled Study

Suez Canal University1 site in 1 country16 target enrollmentStarted: August 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
16
Locations
1
Primary Endpoint
clinical assessment of primary stability of dental implant

Study Overview

Brief Summary

Clinical and Radiographic Assessment of the Outcomes of Dental Implant Inserted after Xenograft Socket Preservation in Posterior Maxilla: A Randomized Controlled Study

Detailed Description

Dental implants have become a common choice among the treatment options for missing teeth rehabilitation and has remarkably high survival and success rates Since the introduction of implants into clinical practice more than several decades ago. The success rate of dental implants, over the last ten years, has been about 90- 95%.

Invasive and non-invasive clinical tests are available like histomorphometric analysis, radiographic analysis, push- and pull-out tests, percussion tests, Periotest and resonance frequency analysis (RFA) are employed to assess the steadiness of dental implants to assess objectively implant stability at different stages of its service life to verify successful implantation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Male patients aged between 21 and 40 years.
  • •General good health.
  • •Absence of any relevant systemic disease.
  • •Presence of a hopeless maxillary posterior tooth that requires extraction.
  • •Extraction site suitable for replacement by a dental implant.
  • •Cases have adequate bone width and length.
  • •Volunteer subjects must sign an informed consent.

Exclusion Criteria

  • •Poor oral hygiene with no possibility of improvement.
  • •Smokers (more than 10 cigarettes per day).
  • •Chronic treatment with any medication known to affect oral status and bone turnover.
  • •Drug or alcohol abuse.

Arms & Interventions

socket preserved

Active Comparator

(8 cases): was treated by immediate socket preservation with S1-XB xenograft augmentation after extraction.

Intervention: socket preserved (Device)

non preserved sockets

Placebo Comparator

(8 cases): was not exposed to any type of socket preservation after the extraction procedure.

Intervention: non preserved socket (Device)

Outcomes

Primary Outcomes

clinical assessment of primary stability of dental implant

Time Frame: immediately and after four months • A ratchet was used to place the implant immediately The implant stability using OSTELL device was taken immediately postoperative implant insertion and was assessed after 4 months before prothesis

implant stability assessment by 1. rachet insertion torque * The implant was installed into the osteotomy site using the motorized method with the engine set at 50 rpm and 35-50 N/cm torque. * A ratchet was used to place the implant to the desired depth when the insertion torque was more than 35N/cm torque. 2. osstell device (ISQ) Make it possible to monitor osseointegration in a precise and objective manner. * Osstell helps to objectively and non-invasively determine implant stability. The prob attached to the instrument via a cable and measurements are displayed on the black lit display. * The device held in a right angle to the center toward the implant to be examined, the maximum deviation angle from the orthoradial direction of percussion is 45 degrees. In addition, the rod and the test surface must maintain 0.6-2.5 mm distance according to the operating instructions. * The implant stability using OSTELL device was taken immediately postoperative and was assessed after 4 months

radiographic assessment of implant stability

Time Frame: 1.Pre-operative radiographic evaluation: before implant placement 2.Intra oral paralleling periapical direct digital radiographic procedure: immediately after placement and after four months

1. Pre-operative radiographic evaluation: After a healing period of four months, all the patients evaluated by Scanora 3D Cone Beam Computed Tomography scanner (CBCT) for evaluation bucco-lingual dimention, mesio-distal width, relation to neighbouring vital structures, bone density and assessment good position for implant placement. Post-operative Digital Radiography Assessment: 2. Intra oral paralleling periapical direct digital radiographic procedure: Indirect Standardized digital radiographs were achieved using KaVo Scan eXam™M One and the Rinn extension cone paralleling (XCP) periapical film holder. The KaVo Scan eXam™M One is an Intraoral digital imaging plate system (psp) system using Imaging plate which is a film-like thin, flexible, and wireless phosphorescent plate, which works as a wireless receptor.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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