RECRUITING

Evaluation of Free Gingival Graft Timing

Conditions

Ridge Augmentation Alveolar Mucosa Attached mucosa Dental implants

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This clinical trial aims to compare and evaluate the clinical outcomes between two distinct treatment sequences: free gingival graft surgery preceding guided bone regeneration and guided bone regeneration followed by free gingival graft.

Official Title

Evaluation of Free Gingival Graft Timing in Staged Guided Bone Regeneration: A Randomized Controlled Trial

Quick Facts

Study Start:2024-08-12

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06294587

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* • At least 18 years old * No uncontrolled medical conditions or medications that will affect their bone healing. * Good oral hygiene is defined as a full-mouth plaque score ≤25%11. * Must be able to read and understand the informed consent document. * Has a need for implants to replace missing tooth/teeth in at least 1 quadrant of the mouth. * Insufficient alveolar ridge width for endosseous implant placement, defined as 5 mm or less, as determined by bone sounding and CBCT scan. * The patient and/or guardian is willing and able to comply with pre-operative and post-operative diagnostic and clinical evaluations required. * The patient is not pregnant or breastfeeding.	* Active infectious diseases. * Liver or kidney dysfunction/failure. * Uncontrolled diabetes (HbA1c ≥ 8.5). * Active cancer treatment - such as active chemotherapy radiation therapy, or radiotherapy performed within ≤12 months from the procedure. * Taking medications that will affect their bone healing (for example, bisphosphonates and long-term anti-inflammatory medications). * Metabolic bone diseases that affect bone healing such as osteoporosis. * Pregnant or lactating women (self-reported). * Current tobacco and Marijuana smokers have 10 or more cigarettes per day, and former smokers (\> 10 cigarettes) who quit \< 10 ago (self-reported). * Poor oral hygiene. * Vertical loss of bone at the edentulous ridge. * History of periodontal disease. * The patient is pregnant or breastfeeding

Inclusion Criteria

Exclusion Criteria

* • At least 18 years old
* No uncontrolled medical conditions or medications that will affect their bone healing.
* Good oral hygiene is defined as a full-mouth plaque score ≤25%11.
* Must be able to read and understand the informed consent document.
* Has a need for implants to replace missing tooth/teeth in at least 1 quadrant of the mouth.
* Insufficient alveolar ridge width for endosseous implant placement, defined as 5 mm or less, as determined by bone sounding and CBCT scan.
* The patient and/or guardian is willing and able to comply with pre-operative and post-operative diagnostic and clinical evaluations required.
* The patient is not pregnant or breastfeeding.

* Active infectious diseases.
* Liver or kidney dysfunction/failure.
* Uncontrolled diabetes (HbA1c ≥ 8.5).
* Active cancer treatment - such as active chemotherapy radiation therapy, or radiotherapy performed within ≤12 months from the procedure.
* Taking medications that will affect their bone healing (for example, bisphosphonates and long-term anti-inflammatory medications).
* Metabolic bone diseases that affect bone healing such as osteoporosis.
* Pregnant or lactating women (self-reported).
* Current tobacco and Marijuana smokers have 10 or more cigarettes per day, and former smokers (\> 10 cigarettes) who quit \< 10 ago (self-reported).
* Poor oral hygiene.
* Vertical loss of bone at the edentulous ridge.
* History of periodontal disease.
* The patient is pregnant or breastfeeding

Contacts and Locations

Study Contact

Hussein Basma, DDS, MS

CONTACT

205-975-2888

basma86@uab.edu

Sarah Startley, DMD

CONTACT

205-975-8711

ss1971@uab.edu

Study Locations (Sites)

Unversity of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, 35294-0007

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-12

Study Completion Date2027-08

Study Record Updates

Study Start Date2024-08-12

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

Ridge Augmentation
Attached mucosa
Dental implants

Additional Relevant MeSH Terms

Ridge Augmentation
Alveolar Mucosa