Evaluation of the Efficacy of Allograft Versus Tenting Technique in Open Sinus Lifting With Immediate Implant Placement

Evaluation of the Efficacy of Allograft Versus Tenting Technique in Open Sinus Lifting With Immediate Implant Placement A Randomized Clinical Trial

Implant placement in deficient posterior maxilla is a challenging clinical situation that necessitates appropriate treatment options to restore this area.

-Aim of the study: To compare allograft vs tenting technique in terms of implant stability and bone height.

Study Overview

• Status: Not yet recruiting
• Conditions: Implant Complication; Surgery-Complications; Sinus; Dental
• Intervention / Treatment: Other: Sinus lifting without graft; Procedure: Sinus lifting with allograft

Detailed Description

Rationale for carrying out the trial:

The research population will be divided into two groups. Group1 will be treated by allograft with immediate implant technique, Group2 will be treated by tenting technique with immediate implant technique. Allograft has been effective in augmenting bone growth and has been proven to be a vital asset in sinus lifting.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amira R Elshikh, BCS; Phone Number: 01068503398; Email: Amira.raafat2512@gmail.com
• Study Contact Backup: Name: Salma H Abdelaty; Phone Number: 0 111 399 9772

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patient with missing upper pre molar , molar teeth
2. Patients in need of bone grafting of the maxillary sinus to house an implant.
3. Patients with residual alveolar crest of at least 3-4mm in height and 5mm in width distal to the canine as measured on CBCT scan
4. Patients with adequate inter-arch space

Exclusion Criteria:

1. Patients suffering from any sinus pathosis.
2. Patients who are heavy smokers (>10 cigarettes/day).
3. Patient under psychiatric therapy or unrealistic expectations
4. Patients of systemic conditions that may interfere with carrying out the surgical procedure.
5. Lack of opposite occluding dentition/prosthesis in the area intended for implant placement
6. Severe bruxism or clenching
7. Poor oral hygiene (full mouth bleeding on probing and full mouth plaque index >25%)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sinus lifting without graft (control ); Patients will receive sinus lifting with immediate implant placement without graft placement.	Other: Sinus lifting without graft; Participants will receive sinus lifting with immediate implant in premolar-molar area without graft; Other Names: Tenting technique
Experimental: Sinus lifting with graft (intervention); Patients will receive sinus lifting with immediate implant and allograft placement.	Procedure: Sinus lifting with allograft; Participants will receive sinus lifting and allograft with immediate implant in premolar-molar area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability	implant stability quotient(ISQ) is the evaluation unit set to determine the correct isq<60:low stability isq 60-65 : medium stability isq >70: high stability stability of the implant, this module by means of a resonance frequency analysis (rfa) applied to the bone manages to measure stability on an isq scale from 1 to 100 (khz):	During the implant placement procedure and after 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone hight	Newly formed bone length will be measured on cone beam ct by millimeter	Before surgery and after 6 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Fouad W, Osman A, Atef M, Hakam M. Guided maxillary sinus floor elevation using deproteinized bovine bone versus graftless Schneiderian membrane elevation with simultaneous implant placement: Randomized clinical trial. Clin Implant Dent Relat Res. 2018 Jun;20(3):424-433. doi: 10.1111/cid.12601. Epub 2018 Mar 25.
• Karagah A, Tabrizi R, Mohammadhosseinzade P, Mirzadeh M, Tofangchiha M, Lajolo C, Patini R. Effect of Sinus Floor Augmentation with Platelet-Rich Fibrin Versus Allogeneic Bone Graft on Stability of One-Stage Dental Implants: A Split-Mouth Randomized Clinical Trial. Int J Environ Res Public Health. 2022 Aug 4;19(15):9569. doi: 10.3390/ijerph19159569.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Sinus lifting

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No