Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-28 @ 6:32 PM
Study NCT ID:
NCT07060859
Status:
COMPLETED
Last Update Posted:
2025-07-15
First Post:
2025-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Dexamethasone, Ascorbic Acid, and BGP for Enhancing Implant Osseointegration
Sponsor:
Manar Ziad Foura-Matar
Organization:
Study Overview
Official Title:
The Influence of The Topical Combined Application of Dexamethasone, Ascorbic Acid, and β-Sodium Glycerophosphate on Implant Osseointegration: A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DAG
Brief Summary:
The goal of this clinical trial was to evaluate whether the topical application of a combination of dexamethasone, ascorbic acid, and β-sodium glycerophosphate could enhance implant osseointegration in adult dental implant patients. The main question it aimed to answer was:
Did the combined topical use of these agents improve implant stability during the healing phase?
Researchers compared intervention implants (which received the topical agents at the implant site) to control implants (which received standard placement without topical application) within the same participant, in order to assess differences in implant stability and osseointegration.
Participants:
Underwent dental implant surgery.
Received both the topical treatment and the standard procedure, applied to different implant sites.
Returned for follow-up visits, where implant stability was measured using resonance frequency analysis (RFA) at predefined time intervals.
Did the combined topical use of these agents improve implant stability during the healing phase?
Researchers compared intervention implants (which received the topical agents at the implant site) to control implants (which received standard placement without topical application) within the same participant, in order to assess differences in implant stability and osseointegration.
Participants:
Underwent dental implant surgery.
Received both the topical treatment and the standard procedure, applied to different implant sites.
Returned for follow-up visits, where implant stability was measured using resonance frequency analysis (RFA) at predefined time intervals.
Detailed Description:
This randomized clinical trial was conducted to investigate the effect of the topical application of a combination of dexamethasone, ascorbic acid, and β-sodium glycerophosphate on the osseointegration of dental implants. The rationale behind the study was based on existing evidence suggesting that these agents may enhance bone healing, reduce inflammation, and support mineralization when applied locally.
Each participant received two dental implants: one designated as the intervention site (treated with the topical combination of the three agents at the time of implant placement), and the other as the control site (placed without any topical application). This split-mouth design allowed intra-individual comparison, minimizing the influence of patient-related variability.
Implant stability was assessed using resonance frequency analysis (RFA) at four follow-up intervals to evaluate differences in osseointegration between the two sites. The study aimed to determine whether the adjunctive use of these agents could improve early implant stability, potentially contributing to more predictable outcomes in dental implantology.
No investigational drugs or devices were used beyond standard clinical tools. The study was approved by a local ethics committee, and informed consent was obtained from all participants prior to enrollment.
Each participant received two dental implants: one designated as the intervention site (treated with the topical combination of the three agents at the time of implant placement), and the other as the control site (placed without any topical application). This split-mouth design allowed intra-individual comparison, minimizing the influence of patient-related variability.
Implant stability was assessed using resonance frequency analysis (RFA) at four follow-up intervals to evaluate differences in osseointegration between the two sites. The study aimed to determine whether the adjunctive use of these agents could improve early implant stability, potentially contributing to more predictable outcomes in dental implantology.
No investigational drugs or devices were used beyond standard clinical tools. The study was approved by a local ethics committee, and informed consent was obtained from all participants prior to enrollment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: