NCT06443476

Brief Summary

To evaluate a novel method using a designed tenting abutment to reduce number of surgeries and the edentulous healing period is shortened. In addition, to prevent vertical and horizontal collapse of the bone graft and minimizes resorption of the bone graft during the healing the atrophic posterior mandible. The tent pole provides excellent mechanical properties; stability \& fixation, yet very poor features to preserve the integrity of the soft tissue. Using the tenting abutment technique will help preserve the soft tissue and decrease the amount of dehiscence that might accompany the use of the tent pole.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

June 5, 2024

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

May 30, 2024

Last Update Submit

May 30, 2024

Conditions

Keywords

SANTAtent abutmentTent pole

Outcome Measures

Primary Outcomes (1)

  • height gained and width gained

    height gained and width gained Measure unit milimerter (mm) Measure device :CBCT

    before and post operative four months

Secondary Outcomes (1)

  • Soft tissue dehiscence

    after one month

Study Arms (2)

conventional group

ACTIVE COMPARATOR

Using a tent pole to gain bone in the atrophic posterior mandible.

Procedure: Tent pole technique

study group

ACTIVE COMPARATOR

Using a Tenting abutment to gain bone in the atrophic posterior mandible

Procedure: Tenting abutment technique

Interventions

To evaluate a novel method using a designed tenting abutment to reduce number of surgeries and the edentulous healing period is shortened. In addition, to prevent vertical and horizontal collapse of the bone graft and minimizes resorption of the bone graft during the healing the atrophic posterior mandible.

study group

using the Tent pole technique to gain bone vertical and horizontal loss

conventional group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with atrophic posterior mandible.
  • Both sexes.
  • No intraoral soft and hard tissue pathology.
  • No systemic condition that contraindicates implant placement

You may not qualify if:

  • Local criteria:
  • Untreated gingivitis, periodontitis.
  • Insufficient oral hygiene.
  • Previous radiation therapy for the head and neck neoplasia, or bone augmentation to implant site..
  • Systemic criteria:
  • Systemic disorders.
  • Heavy smoking of more than 20 cigarettes per day.
  • Bone pathology.
  • ·Psychiatric problems. Emotional instability. Unrealistic aesthetic demands.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alaa Mohammed Hafedh

Cairo, Egypt

RECRUITING

Study Officials

  • Mohamed ahmed Farid shehab, professor

    supervisor

    STUDY DIRECTOR

Central Study Contacts

alaa Mohammed Hafedh, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Evaluate bone gained (height and width) and the period of time of healing in the atrophic posterior mandible when using the tenting abutment technique compared to the tent pole
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PRINCIPLE INVESTIGATOR

Study Record Dates

First Submitted

May 30, 2024

First Posted

June 5, 2024

Study Start

October 1, 2023

Primary Completion

July 1, 2024

Study Completion

October 1, 2024

Last Updated

June 5, 2024

Record last verified: 2023-06

Locations