NCT07171476

Brief Summary

Introduction: Replacing single rooted teeth with immediate implant is quit challenging in the anterior region where the buccal bone is usually deficient, moreover the bone loss increases with the extraction of tooth and the cutting of the blood supply from the periodontal ligament. With the normal bone loss around successful implant about 0.2 mm per year, its essential to start with enough buccal bone bulk to ensure long survival of the implant. The main disadvantage of guided bone regeneration is the inability of the membrane to protect the graft from the forces exerted during suturing of the flap at the end of the procedure and the forces exerted by the patient's muscles during mastication, leading to displacement of the bone graft. Tent pole technique suggest the use of monocortical screws to support the membrane preventing displacement of the bone graft. Bone ring technique suggest surrounding the implant by ring of bone which is fixed in place by the implant itself. Aim: The aim of the study is to evaluate the effect of Bone Ring technique, and Tent-Pole technique on buccal/Labial bone with immediate implant placement. Methodology: Clinical study will be done in 24 cases of single rooted teeth with deficient buccal bone and require replacement with immediate implant. The 24 cases will be divided into three groups ,8 cases each. In group A, immediate implant will be placed with traditional guided bone regeneration, in which the buccal bone will be enhanced by autogenous bone chips obtained from the symphysis area and then covered by resorbable membrane. In group B, immediate implant will be placed with bone ring technique, in which autogenous bone ring obtained from the symphysis will be placed around the implant and fixed in place by the implant itself. In group C, immediate implant will be placed with tent pole technique, in which monocortical screws will be placed to support the membrane covering the autogenous bone chips obtained from the symphysis area. the implant stability will be measured immediate after implant placement and after six months from the surgery using osstel system. The buccal bone volume changes will be measured by cone beam ct.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

4 years

First QC Date

August 16, 2025

Last Update Submit

September 7, 2025

Conditions

Keywords

immediate implantbone ring techniquetent pole technique

Outcome Measures

Primary Outcomes (5)

  • Implant Stability

    stability of the implant will be measured by using a smartpeg which will be placed over the implant and the stability of the implant will be measured using Osstel ISQ system\* in Implant Stability Quotient (ISQ) value in both buccolingual and mesodistal direction with the average between the two reading being recorded.

    Initial stability will be measured immediately after implant insertion before placement of cover screw and final stability will be measured after 6 months from the surgery

  • Bone density

    The same section will be fixed on the immediate post-operative CBCT and the final CBCT by taking the implant as a reference. the reference lines in both the immediate post-operative the final CBCTs will be placed in the middle of the implant at both cross-section view and panoramic view fixing the same section. The idea of using virtual implant is to fix the area measured whereas the area drawn manually can't be fixed in both CBCTs. The virtual implant will be chosen with the same dimension and design of the used implant, placed over the real implant in both the immediate post-operative and the final CBCTs taken 6 months postoperatively. The virtual implant placed over the real implant will then be adjusted in both axial and cross-sectional views. Using the OnDemand3D CBCT analyzing system the density of 2mm thickness of bone around the implant will be measured and converted to Housefield unit.

    To compare the changes in bone density in each group, the bone density around each implant was measured in two main CBCTs, which are the immediate post-operative CBCT and the final CBC taken 6 months postoperatively.

  • Buccal bone height

    The same cut will be fixed in a cross-sectional view with zero thickness in three CBCTs representing preoperative, immediate postoperative and 6 months postoperative. The height of the buccal bone will be measured from the buccal bone crest to a fixed anatomical structure in the three CBCTs. These fixed anatomical structures include floor of the nasal cavity and maxillary sinus in the upper jaw and inferior alveolar nerve and lower border of the mandible in the lower jaw.

    A) Initial change The buccal bone height in preoperative CBCT will be compared to that in the immediate postoperative CBCT B) Final change The buccal bone height in preoperative CBCT will be compared to that in 6 months postoperative CBCT

  • Buccal bone width

    The maximum thickness of buccal bone in the coronal third of implant will be measured in cross sectional views with zero thickness in the three CBCTs representing preoperative, immediate postoperative and 6 months postoperative.

    A) Initial change The buccal bone width in preoperative CBCT will be compared to that in the immediate postoperative CBCT B) Final change The buccal bone width in preoperative CBCT will be compared to that in 6 months postoperative CBCT

  • Full ridge width

    The maximum full ridge thickness in the coronal third of implant will be measured in fixed cross-sectional views with zero thickness in the three CBCTs representing preoperative, immediate postoperative and 6 months postoperative.

    A) Initial change The maximum ridge thickness in preoperative CBCT will be compared to that in the immediate postoperative CBCT B) Final change The maximum ridge thickness in preoperative CBCT will be compared to that in 6 months postoperative CBCT

Study Arms (3)

Guided bone regeneration

ACTIVE COMPARATOR

Traditional guided bone regeneration will be done in which a 3D guided osteotomy will be done and the implant will be inserted, then covered buccally with autogenous bone graft chips and resorbable membrane before flap suturing.

Procedure: Guided bone regeneration

bone ring technique

ACTIVE COMPARATOR

Bone ring technique will be applied in which a trephine bure will be inserted through a 3D guide to prepare the site to receive the bone ring. The osteotomy will be done through the bone ring and the implant will be inserted to fix the implant in place, then covered buccally with autogenous bone graft chips and resorbable membrane before flap suturing.

Procedure: bone ring technique

tent pole technique

ACTIVE COMPARATOR

tent pole technique will be applied in which two monocortical screws will then be inserted using 3D guide, mesial and distal to the implant and extending 3 mm outside the bone, then covered buccally with autogenous bone graft chips and resorbable membrane before flap suturing.

Procedure: Tent pole technique

Interventions

traditional guided bone regeneration will be done in which a flap will be raised under local anesthesia, followed by atraumatic extraction of the tooth, after which a 3D guided osteotomy will be done and the implant will be inserted, then covered buccally with autogenous bone graft chips and resorbable membrane before flap suturing

Guided bone regeneration

bone ring technique will be applied in which the same procedure as group A will be followed till tooth extraction, after which a trephine bure will be inserted through a 3D guide to prepare the site to receive the bone ring. The osteotomy will be done through the bone ring and the implant will be inserted to fix the implant in place, then covered buccally with autogenous bone graft chips and resorbable membrane before flap suturing.

bone ring technique

tent pole technique will be applied in which the same procedure same as group A will be followed till implant insertion. Two monocortical screws will then be inserted using 3D guide, mesial and distal to the implant and extending 3 mm outside the bone, then covered buccally with autogenous bone graft chips and resorbable membrane before flap suturing.

tent pole technique

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with physical status classified as ASA class I and class II having single rooted tooth with buccal bone defect extending less than 3 mm from the alveolar bone crest which requires replacement.
  • There is bone extending at least 3mm beyond the root apex.

You may not qualify if:

  • Patients with physical status classified as ASA class III, class IV or class V.
  • Buccal bone defect extending more than 5 mm from the alveolar bone crest.
  • Smoker patient.
  • Presence of acute or chronic infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez Canal University

Ismailia, Ismailia Governorate, 41511, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2025

First Posted

September 12, 2025

Study Start

March 15, 2021

Primary Completion

March 10, 2025

Study Completion

August 20, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations