A Clinical Comparison of Connective Tissue Graft and Alb-PRF for Rebuilding Interdental Papilla

ConditionPapilla Reconstruction

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-55

Sponsorshaimaa hamdy

About this trial

The interdental papilla, a small wedge of gingival tissue positioned between adjacent teeth, plays a crucial role in both dental esthetics and oral function. Loss or deficiency of the papilla results in the formation of "black triangles," which not only compromise a patient's smile but also lead to challenges such as food impaction, phonetic difficulties, and increased risk of periodontal disease. The reconstruction of the interdental papilla is recognized as one of the most challenging procedures in periodontal therapy, particularly when aiming for enhanced esthetic outcomes and patient satisfaction

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 20-55 years

Nordland and Tarnow Class I/II papillary loss

Good oral hygiene (FMPS & FMBS <20%)

Systemically healthy

Disqualifiers

Smoking

Periodontal pockets >4 mm in the target site

History of systemic diseases or medications affecting healing

Pregnant or lactating women

Trial design

Design model

Parallel

Treatments tested in this trial

Albumin (5% serum-protein solution containing immunoglobulins)
Biological/Vaccine
* Preoperative Phase: * Oral hygiene instruction * Phase I periodontal therapy * Initial photography and papillary height measurements using digital calipers or customized stents * Surgical Technique: * Local anesthesia * Intrasulcular incision around target teeth * Papilla preservation flap * Harvesting CTG from the palate * Injection of liquid Bio-PRF at the papillary base (test group) * CTG positioned in the papilla region * Suturing with microsurgical technique * Postoperative Protocol: * Analgesics (e.g., ibuprofen 400 mg) * Chlorhexidine 0.12% mouth rinse for 2 weeks * Suture removal at 10-14 days * Follow-up at 1 month, 3 months, and 6 months
connective tissue graft
Biological/Vaccine
Local anesthesia. Intrasulcular incision around target teeth. Papilla preservation flap. Harvesting CTG from the palate

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: connective tissue graftPlacebo comparator 1 intervention

Group B: albumin-PRFActive comparator 1 intervention

Trial outcomes

Primary outcomes

Papilla Height Gain

Papilla Height Gain (measured from contact point to papilla tip)

Time frame

6 months follow up

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

shaimaa hamdy

Lead sponsor

Minia University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: