Socket Augmentation Using Minimally Invasive Approach

Phase 2

Completed

• Conditions: Periodontitis with Mobility that require extraction and in future to be replaced using dental implants.

• Registration Number: CTRI/2017/09/009867
• Lead Sponsor: Teethanker Mahaveer University

Brief Summary

**Aim and Objectives of the study:** A Randomized ControlledClinical study was conducted to evaluate and compare the efficacy of Microsurgical over Macrosurgical technique usingSynthetic NanocrystallineHydroxyapatite (Sybograf- plus™) andβ-tricalcium phosphate Composite bone graft and bioresorbable collagenmembranes made of Type – I collagen (Healiguide) TM for socket augmentation

**Materialsand Methods:** A total of30extraction sites from 9 patients, aged 30 to 55 years were selected foraugmentation of socket immediately after the tooth extraction. Equal number of sites were selectedfrom each patients and randomly divided into Control (Macrosurgical) sites and Test(Microsurgical) sites. The clinical evaluation of Test and Control sites wasdone at baseline, 3, 6 and 9 months for Mesiobuccal, MidBuccal, Distobuccaland MidLingual/Palatal measurements.Post-operative vascularity was evaluated by Ultrasound Doppler Flowmetry atbaseline, 10th Day and 1 month. Radiological assessment was done at baseline,6 and 9 months for socket height, Buccolingual width at1/4th , 1/2 and 3/4th height of  the socket, mesio-distalwidth of the socket and the bone density recorded at apical, middle andcoronal, buccal, palatal, mesial and distal wall of socket on Dentascan inHounsfield units (HU).

**Results:**Increase insocket height was observed in Test sockets at 9 months which was statistically significantas compared to Control ones.Test group demonstrated better vascularization as compared to Controlgroup at 10 day and 1 month and all changes are statistically significant in Testgroup (p<0.05) . Boneformation and density (HU) was found to be significantly higher in Test group (p= .000) as compared to Control group both at 6 months as well as at 9 months.

·        **Conclusion:** SignificantGain in alveolar bone height was observed at the end of nine months in both Testand Control groups clinically.

·        Ultrasound Doppler Flowmetry revealedsuperior vascularization of Microsurgically/Test treated sites in initial phaseof wound healing than the traditional /Conventional/Control one.

·        Extended surgical time of Microsurgicalapproach was compensated for faster vascularization with rapid healing of siteleading to more predictable gingival contour with improved esthetic outcomethan the Control one. Substantial enhancement of immediate postsurgicalesthetics of a Microsurgical site to that of Macrosurgical one wasdemonstrated.

·        Radiographically, sagittal sectionsconfirmed significant increase in the socket height and buccolingual width onCT scan with significant increase in the density of bone in both Test andControl groups.

 **Keywords:**Biphasic hydroxyapatite; Collagen membrane; Dentascan; Microsurgical; Socketaugmentation; Ultrasound Doppler Flowmetry.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-24
• Study Completion: 2016-06-26
• Last Update Posted: 2017-09-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1 Sockets of extracted teeth having atleast 7mm residual alveolar bone height as measured clinically and radiographically with intact socket walls.
• 2 Anterior teeth with grade 3 mobility and having hopeless prognosis 3 No systemic disorders.

Exclusion Criteria

• 1 Any systemic diseases where periodontal surgery is contraindicated.
• 2 History of drug allergy.
• 3 Pregnant patients.
• 4 Smoking or tobacco chewing.
• 5 Presence of periapical pathology 6 Root surface restorations.
• 7 Root caries that would require restorations.
• 8 Failure to complete the informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Crestal height	(all in milli meters) at Baseline, at 10 Day, at 1,3, 6,9 and 12 Months
Mesiobuccal, Mid Buccal, Distobuccal, and Midlingual	(all in milli meters) at Baseline, at 10 Day, at 1,3, 6,9 and 12 Months
Color Doppler Flowmetry ( in PSV)	(all in milli meters) at Baseline, at 10 Day, at 1,3, 6,9 and 12 Months

Secondary Outcome Measures

Name	Time	Method
Crestal height	Mesiobuccal, Mid Buccal, Distobuccal, and Midlingual

Trial Locations

Locations (1)

Teethanker Mahaveer University; 🇮🇳 Moradabad, UTTAR PRADESH, India

Teethanker Mahaveer University

🇮🇳Moradabad, UTTAR PRADESH, India

Deepali Jain

Principal investigator

8171992408

drdeepali1026@gmail.com