to verify and compare Crestal bone levels and implant stability for dental implants when they are placed and immediately loaded in grafted and non-grafted bone- split mouth study

Not yet recruiting

• Conditions: Partial loss of teeth, (2) ICD-10 Condition: K084||Partial loss of teeth,

• Registration Number: CTRI/2021/02/031135
• Lead Sponsor: SAKSHI RAWAL

Brief Summary

The study was conducted in Department of Prosthodontics, Crown and Bridge and Oral Implantology, SGT University, Gurugram. It was carried out on local patients who had grossly decayed teeth with poor prognosis, one in each quadrant in  mandible. The replacement of the tooth was done with endosseous dental implants. The main aim of the study was to evaluate and compare crestal bone levels and implant stability in immediately loaded dental implants in grafted and non-grafted site.

A total of 20 implants were placed in 10 patients. All the patients underwent extraction and implant placement under local anaesthesia. Post extraction, in one of the two quadrants collagen plug is used as the graft material (Test group), and the opposite site is left for spontaneous healing (Control group). After the time interval of 3 months, implants are placed in both the sites i.e grafted and non-grafted. At the time of implant placement, the implants are immediately loaded for both test and control groups. Crestal bone levels were evaluated by means of standardized RVG’s at the time of implant placement, and at time intervals of 1month,3 month,6 months respectively for both groups. Implant stability was measured to assess the level of osseointegration. OstellTMwas used to measure the stability of implant at the time of implant placement, 1 month, 3 month, 6 month post-operatively.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-20
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients having grossly decayed or grade III mobile mandibular posterior teeth indicated for extraction and willing for tooth replacement, without any acute exudate/pus.
• Patients having minimum available alveolar bone height of 3-4 mm present apically from the base of the extraction socket at the restorative site.
• Patients having minimum available inter occlusal space of 8-10 mm at the restorative site.
 4.
• Patients with good oral hygiene.
 5.
• Patients who do not have any known systemic disease.
.

Exclusion Criteria

• 1 .According to ASA Classification Class 4 patients
 Organic heart disease with marked signs of cardiac insufficiency.
 Recent myocardial infarction of less than 6 months duration.
 Unstable angina.
 Patients with advanced degrees of pulmonary, renal or endocrine insufficiency.
 2 .According to ASA Classification Class 3 patients Uncontrolled diabetes with complications to vascular or other organs, i.e., retinopathy, neu- ropathy, etc.
 3.
• Immunocompromised patients.
• Blood dyscrasias 5.
• Occlusal anomalies Deep Bite Cross Bite 6.
• Para-functional Habits • 7.
• Heavy smokers (more than 10 cigarettes per day).
 8.
• Alcohol abusers.
 9.
• Recent history of any acute illness .
 • • • • • • • Bruxism 6.
• Radiation therapy in orofacial region
 6 10.
• Patients having unrealistic expectations and psychological problems.
• Local Factors : Insufficient inter-arch space Edentulous opposing arch (maxillary arch)
 Intraoral draining sinus in relation to the proposed implant site
 Perforation and/or loss of labial bony plate during extraction
 Radiographically assessed jumping space greater than 2mm circumferentially
 Unfavourable implant axis orientation Patients with TMJ disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IMPLANTS STABILITY AND CRESTAL BONE LEVELS SIMILAR FOR BOTH GRAFTED AND NON-GRAFTED SITES	BASELINE, 1 MONTH, 3 MONTH, 6 MONTHS

Secondary Outcome Measures

Name	Time	Method
IMPLANT STABILITY AND CRESTAL BONE LEVELS IN IMMEDIATELY LOADED IMPLANTS ARE SIGNIFICANT FOR EACH GROUP AND NON-SIGNIGICANT WHEN COMPARED IN GRAFTED AND NON-GRAFTED SITE.	BASELINE, 1 MONTH, 3 MONTH, 6 MONTHS

Trial Locations

Locations (1)

SGT UNIVERSITY; 🇮🇳 Gurgaon, HARYANA, India

SGT UNIVERSITY

🇮🇳Gurgaon, HARYANA, India

DR SAKSHI RAWAL

Principal investigator

9810155281

SAKSHI.RWL11@GMAIL.COM