Pontic Site Development With or Without Fixed Partial Denture

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

This study aims to evaluate the effectiveness of soft tissue augmentation using connective tissue graft (CTG) in pontic site defects. It compares clinical and volumetric outcomes between sites with an existing fixed partial denture (FDP) and sites without an FDP.

Following tooth extraction, alveolar ridge resorption often leads to soft tissue defects that can compromise esthetics, function, and prosthetic outcomes. CTG is considered the gold standard for soft tissue augmentation due to its predictable improvement in tissue thickness and stability.

In this non-randomized clinical trial, patients with single edentulous sites in the esthetic zone will undergo CTG using a standardized surgical technique. The primary outcome is keratinized tissue thickness, while secondary outcomes include keratinized tissue width, volumetric soft tissue changes, esthetic evaluation (Pink Esthetic Score), plaque index, post-operative pain, and patient satisfaction.

Clinical and digital assessments will be conducted preoperatively and at follow-up intervals up to 6 months. The study aims to determine whether performing CTG around an existing bridge provides comparable or improved outcomes compared to sites without a bridge, potentially offering a less invasive alternative to prosthetic replacement.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients will on missing tooth in the esthetic zone (2nd premolar to 2nd premolar), missing at least 3 months prior to recruitment, with or without FPD

Systemically free patient

≥18 years of age

Intact gingival tissue with at least 2mm keratinized tissue in adjacent teeth

Disqualifiers

Smokers.

Pregnancy and lactation

Periodontitis

Severe gagging reflex

Trial design

Design model

Parallel

Treatments tested in this trial

  • Connective Tissue Graft (CTG)

    Procedure/Surgery

    Soft tissue augmentation will be performed using a subepithelial connective tissue graft (CTG) harvested from the palate and placed at the pontic site using a minimally invasive pouch/tunnel technique. The procedure aims to increase soft tissue thickness and improve contour in edentulous ridge defects. The same surgical protocol will be applied in all participants, with variation based only on the presence or absence of an existing fixed partial denture.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: CTG with Existing Fixed Partial DentureExperimental treatment 1 intervention
Group B: CTG without Fixed Partial DentureExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Keratinized Tissue Thickness

Measured in millimeters using transgingival probing

Time frame
Baseline and 6 months

Secondary outcomes

1

Keratinized Tissue Width

Measured in millimeters using periodontal probe

Time frame
Baseline and 6 month
2

Volumetric contour changes

Assessed using digital intraoral scanning and 3D analysis

Time frame
Baseline, 3 months, and 6 months
3

Pink Esthetic Score (PES)

It consists of seven variables, each scored 0-1-2 (with 2 being best), for a maximum score of 14, assessing papillae, tissue level, contour, color, texture, and alveolar process.

Time frame
6 months
4

Blinded assessment for esthetics

Calibration of the Assessors: Before initiating clinical measurements, 3 assessors will undergo calibration to ensure reliability and reduce intra-examiner variability. The calibration will aim for a kappa (κ) value greater than 0.75 to confirm consistency. The assessors will be trained to score according to the PES Blinding of the Assessors: The assessors will be masked and remain unaware of treatment group assignments. Assessors will not be any part of the ttt process

Time frame
6 months

Other outcomes

Sponsors and contacts

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