Mandibular Distal-extension ProsthesesNCT06871020

Periodontal Health and Patient Satisfaction of CAD/CAM Fiber-Reinforced vs. PFM Attachments in Distal Extension RPDs

A study testing Mandibular removable partial denture retained on OT extracoronal attachment made from fiber-reinforced composite resin and Mandibular removable partial denture retained on OT extracoronal attachment made from porcelain-fused to metal in people with Mandibular Distal-extension Prostheses, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for: Mandibular Distal-extension Prostheses
What is being tested?: Mandibular removable partial denture retained on OT extracoronal attachment made from fiber-reinforced composite resin and Mandibular removable partial denture retained on OT extracoronal attachment made from porcelain-fused to metal
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteEgypt
Study dates: 1 Jan 2025to 15 Mar 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Mandibular partially edentulous bilateral distal extension Kennedy Class I with canines and first premolars as last abutments.
The opposing maxillary arch will be dentate.
Angle class I maxillomandibular skeletal relation.
The distal extension ridge will be well-formed and covered by healthy and firm mucosa.
As verified by periapical radiographs, Abutments have healthy periodontal ligaments and an appropriate crown/root ratio (CRR).
Crown/root ratio of the premolar abutment teeth is not less than 1:1. 5.
The vertical distance between the ridge tissue and the opposing teeth of the study cases is not less than 7 mm. 6.
The buccolingual dimension of the abutment teeth is not less than 6 mm.

Who cannot join

Patients with any systemic disease that could affect the rate of bone resorption, which was confirmed by obtaining a through medical history.
Patients with parafunctional habits (bruxism and clenching).
Patients with any septic foci or impacted teeth as proved by panoramic radiograph, as well as patients with tilted or rotated abutments or soft tissue undercuts in areas that will be involved in the RDP design.
Patients with any TMJ problems.
Patients with any neuromuscular diseases.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Dentistry Ain Shams University
Cairo, 12345

Other trials in Egypt

About this study

Official title: Evaluation of Periodontal Health and Patient Satisfaction of CAD/CAM Fiber-Reinforced Composite Versus Porcelain Fused to Metal Extracoronal Attachment in Mandibular Distal Extension Removable Partial Dentures: A Randomized Clinical Trial

This randomized clinical trial aims to assess periodontal health and patient satisfaction in mandibular distal extension removable partial dentures using CAD/CAM fiber-reinforced composite versus porcelain-fused-to-metal extracoronal attachments. Twenty-four participants with bilateral mandibular Kennedy Class I, retaining only the canines and first premolars as the last standing abutments bilaterally, will be randomly assigned to two groups. Group I (n=12) will receive OT extracoronal attachments made from CAD/CAM fiber-reinforced composite, while Group II (n=12) will receive OT extracoronal attachments made from porcelain-fused-to-metal. All participants will then receive a metallic removable partial denture. The null hypothesis states that no significant differences will be observed in periodontal health and patient satisfaction between the two attachment types.

Read the detailed description

Twenty four participants with bilateral maxillary Kennedy Class I, with the canines and first premolars as the last standing abutments, will be recruited based on strict inclusion criteria from the oral and maxillofacial prosthodontic outpatient clinic. The canines and first premolars (teeth 34,35,44,45) will be prepared to receive OT extracoronal attachments made from either CAD/CAM fiber-reinforced composite (Group I) or porcelain-fused-to-metal (Group II), according to group allocation. All participants will then receive a metallic removable partial denture. Periodontal health will be assessed through bleeding index, probing depth, and gingival recession at denture insertion and after six months and twelve months. Patient satisfaction will also be evaluated at the twelve-month follow-up.

Conditions: Mandibular Distal-extension Prostheses
Being tested: Mandibular removable partial denture retained on OT extracoronal attachment made from fiber-reinforced composite resin, Mandibular removable partial denture retained on OT extracoronal attachment made from porcelain-fused to metal
Keywords: CAD/CAM, Fiber Reinforced Composite, Denture Precision Attachment, Denture, Partial, Removable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mandibular removable partial denture retained on OT extracoronal attachment made from fiber-reinforced composite resinOther
Bilateral OT extracoronal attachments will be milled from fiber-reinforced composite resin after obtaining impressions of the prepared abutments. This will be followed by an overall impression of fabricating a Co-Cr removable partial denture to be retained in the attachments.
Mandibular removable partial denture retained on OT extracoronal attachment made from porcelain-fused to metalOther
Bilateral OT attachments manufactured from porcelain fused to metal by conventional technique after obtaining impressions of the prepared abutments. This will be followed by an overall impression of fabricating a Co-Cr removable partial denture to be retained in the attachments.

Study groups in NCT06871020
Study group	Role	What they receive
OT Extracoronal attachment made from CAD-CAM fiber-reinforced composite resin.	Experimental	The patient will receive a removable partial denture retained by bilateral OT extracoronal attachments made from CAD/CAM fiber-reinforced composite resin. These attachments will be fabricated on the prepared first premolars and canines on each side (34,35,44,45 teeth). Receives: Other: Mandibular removable partial denture retained on OT extracoronal attachment made from fiber-reinforced composite resin
OT Extracoronal attachment made from porcelain-fused-to-metal	Active comparator	The patient will receive a removable partial denture retained by bilateral OT Extracoronal attachment made from porcelain-fused-to-metal . These attachments will be fabricated on the prepared first premolars and canines on each side (34,35,44,45 teeth).. Receives: Other: Mandibular removable partial denture retained on OT extracoronal attachment made from porcelain-fused to metal

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of Bleeding index
The bleeding Index will be evaluated at denture insertion, after six months, and 12 months after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments it will be evaluated according to Lang et al. at four sites per tooth (buccal, lingual, mesiobuccal, and distobuccal) using a UNC-15 probe (Oroax, Woodbridge, Virginia, USA). Bleeding within 30 seconds of gentle probing will be recorded, and the BOP percentage will be calculated as the number of bleeding sites divided by the total number of sites examined, multiplied by 100.
Measured: At denture insertion ( baseline 0) , six months (T1) , and 12 months (T2) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments
Evaluation of Probing Pocket Depth (PPD)
Evaluation of Probing Pocket Depth (PPD)will be evaluated atdenture insertion, after six months, and 12 months after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments . it will be evaluated measured at six sites per tooth using a graduated periodontal probe will be positioned parallel to the tooth's long axis . The distance from the gingival margin to the base of the sulcus or periodontal pocket will be recorded, and mean values will be calculated for each abutment.
Measured: At denture insertion ( baseline 0), six months (T1) , and 12 months (T2) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments
Evaluation Gingival Index (GI)
Evaluation of Gingival index: Evaluated using Löe and Silness (1963), scoring gingival inflammation from 0 (healthy) to 3 (severe inflammation with spontaneous bleeding).
Measured: At denture insertion ( baseline 0), six months (T1) , and 12 months (T2) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments

Secondary outcomes (1)

Evaluation of Patient Satisfaction
Patient satisfaction will be evaluated using the McGill Denture Satisfaction Questionnaire and a visual analog scale (VAS). Satisfaction will be measured across multiple aspects, including ease of cleaning, speech ability, comfort, esthetics, stability, mastication of various foods, masticatory efficiency, oral condition, and overall satisfaction. Patients will rate each item on a 0-100 scale, where 0 represents complete dissatisfaction and 100 indicates total satisfaction.
Measured: After tweleve months (180 days) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202515 Mar 2026

First posted11 Mar 2025
Study start1 Jan 2025
Primary completion1 Jan 2026
Study completion15 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Mandibular Distal-extension ProsthesesStudies of the same condition, open and under way.
More trials run by Ain Shams UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06871020
Sponsor's protocol ID: FDASU-RecIR122439
Status last verified: Nov 2026
First submitted: 22 Feb 2025
Last updated: 5 Nov 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Periodontal Health and Patient Satisfaction of CAD/CAM Fiber-Reinforced Composite Versus Porcelain Fused to Metal Extracoronal Attachment in Mandibular Distal Extension Removable Partial Dentures: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT06871020
Acronym / sponsor ID: FDASU-RecIR122439
Conditions: Mandibular Distal-extension Prostheses
Keywords: CAD/CAM, Fiber Reinforced Composite, Denture Precision Attachment, Denture, Partial, Removable
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Ain Shams UniversityUniversity, hospital or other
Study start: 1 Jan 2025 (actual)
Primary completion: 1 Jan 2026 (actual)
Study completion: 15 Mar 2026 (actual)
First posted: 11 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
OT Extracoronal attachment made from CAD-CAM fiber-reinforced composite resin.	Experimental	Other: Mandibular removable partial denture retained on OT extracoronal attachment made from fiber-reinforced composite resinThe patient will receive a removable partial denture retained by bilateral OT extracoronal attachments made from CAD/CAM fiber-reinforced composite resin. These attachments will be fabricated on the prepared first premolars and canines on each side (34,35,44,45 teeth).
OT Extracoronal attachment made from porcelain-fused-to-metal	Active comparator	Other: Mandibular removable partial denture retained on OT extracoronal attachment made from porcelain-fused to metalThe patient will receive a removable partial denture retained by bilateral OT Extracoronal attachment made from porcelain-fused-to-metal . These attachments will be fabricated on the prepared first premolars and canines on each side (34,35,44,45 teeth)..

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Mandibular partially edentulous bilateral distal extension Kennedy Class I with canines and first premolars as last abutments.
The opposing maxillary arch will be dentate.
Angle class I maxillomandibular skeletal relation.
The distal extension ridge will be well-formed and covered by healthy and firm mucosa.
As verified by periapical radiographs, Abutments have healthy periodontal ligaments and an appropriate crown/root ratio (CRR).

Key exclusion criteria (5 listed)

Patients with any systemic disease that could affect the rate of bone resorption, which was confirmed by obtaining a through medical history.
Patients with parafunctional habits (bruxism and clenching).
Patients with any septic foci or impacted teeth as proved by panoramic radiograph, as well as patients with tilted or rotated abutments or soft tissue undercuts in areas that will be involved in the RDP design.
Patients with any TMJ problems.
Patients with any neuromuscular diseases.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mandibular removable partial denture retained on OT extracoronal attachment made from fiber-reinforced composite resinBilateral OT extracoronal attachments will be milled from fiber-reinforced composite resin after obtaining impressions of the prepared abutments. This will be followed by an overall impression of fabricating a Co-Cr removable partial denture to be retained in the attachments.	Other	OT Extracoronal attachment made from CAD-CAM fiber-reinforced composite resin.
Mandibular removable partial denture retained on OT extracoronal attachment made from porcelain-fused to metalBilateral OT attachments manufactured from porcelain fused to metal by conventional technique after obtaining impressions of the prepared abutments. This will be followed by an overall impression of fabricating a Co-Cr removable partial denture to be retained in the attachments.	Other	OT Extracoronal attachment made from porcelain-fused-to-metal

Primary outcome

Evaluation of Bleeding index
Time frame: At denture insertion ( baseline 0) , six months (T1) , and 12 months (T2) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments
The bleeding Index will be evaluated at denture insertion, after six months, and 12 months after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments it will be evaluated according to Lang et al. at four sites per tooth (buccal, lingual, mesiobuccal, and distobuccal) using a UNC-15 probe (Oroax, Woodbridge, Virginia, USA). Bleeding within 30 seconds of gentle probing will be recorded, and the BOP percentage will be calculated as the number of bleeding sites divided by the total number of sites examined, multiplied by 100.
Evaluation of Probing Pocket Depth (PPD)
Time frame: At denture insertion ( baseline 0), six months (T1) , and 12 months (T2) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments
Evaluation of Probing Pocket Depth (PPD)will be evaluated atdenture insertion, after six months, and 12 months after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments . it will be evaluated measured at six sites per tooth using a graduated periodontal probe will be positioned parallel to the tooth's long axis . The distance from the gingival margin to the base of the sulcus or periodontal pocket will be recorded, and mean values will be calculated for each abutment.
Evaluation Gingival Index (GI)
Time frame: At denture insertion ( baseline 0), six months (T1) , and 12 months (T2) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments
Evaluation of Gingival index: Evaluated using Löe and Silness (1963), scoring gingival inflammation from 0 (healthy) to 3 (severe inflammation with spontaneous bleeding).

1 secondary outcome

Evaluation of Patient Satisfaction
Time frame: After tweleve months (180 days) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Omnia M. Refai, PHD principal investigator

Ain Shams Univeristy

Noha Helmy Hassan Nawar, PHD study director

Ain Shams Univeristy

Heba A. Salama, PHD principal investigator

Misr International University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Bleeding index (time frame: At denture insertion ( baseline 0) , six months (T1) , and 12 months (T2) after delivery of mandibular removable partial denture retained on double OT Extracoronal attachments). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06871020.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.