NCT06139939

Brief Summary

clinical study with guided bone regeneration for deficient alveolar ridge to restore the defect in width and be able to place implant with two different technique

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

November 15, 2023

Last Update Submit

November 15, 2023

Conditions

Keywords

sausage technique

Outcome Measures

Primary Outcomes (1)

  • clinical and radiographic outcome

    clinical ridge width gain

    6 months

Secondary Outcomes (1)

  • histological analysis of remodeled bone.

    6 months

Study Arms (2)

double layer technique

EXPERIMENTAL

include 9 patients will receive lateral alveolar ridge augmentation with double bone graft layer technique for GBR (first layer autograft followed by xenograft second layer

Procedure: Double layer technique

control

OTHER

include 9 patients will receive lateral alveolar ridge augmentation with stander protocol for GBR technique (mixture of autograft and xenograft

Procedure: Double layer technique

Interventions

Double layer technique for alveolar ridge augmentation (first layer autograft followed by xenograft second layer).

controldouble layer technique

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire. (American Society of Anesthesiologists I; ASA I) (Mombelli and Cionca, 2006) 2- Both genders. 3- Age from 20 - 40 years old. 4- Having missing maxillary or mandibular tooth with low or moderate horizontal defect (4-8) according to cologne classification (2013) 5- Presence of sufficient bone height minimum 12 mm that does not require bone grafting or any other ridge augmentation procedure.(Shah and Lum, 2008) 6- Presence of sufficient keratinized mucosa of at least 2 mm.(Bassetti, et al. 2015)

You may not qualify if:

  • Smokers (Twito and Sade, 2014) 2- Vulnerable groups (as pregnant females and decisional impaired individuals) will be excluded from the study.
  • Patients with poor oral hygiene or not willing to perform oral hygiene measures.
  • Prisoners and handicapped patients. 5- Patients with periodontal or periapical infections.(Tonetti, et al. 1996)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university , faculty of dentistry

Cairo, 4543070, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecture

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 18, 2023

Study Start

May 6, 2021

Primary Completion

May 30, 2023

Study Completion

August 30, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations