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

NCT07139392 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: ALB -PRF in papillacommittee 1165
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Papilla Reconstruction

Keywords

ALB-PRF; papilla; connective tissue; reconstruction; MINST

Outcome Measures

Primary Outcomes (1)

• Papilla Height Gain

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

  6 months follow up

Study Arms (2)

connective tissue graft

PLACEBO COMPARATOR

Semi-lunar flap elevation, then connective tissue graft sutured under the flap for papilla reconstruction

Biological: connective tissue graft

albumin-PRF

ACTIVE COMPARATOR

Albumin- PRF for papilla reconstruction

Biological: Albumin (5% serum-protein solution containing immunoglobulins)

Interventions

Albumin (5% serum-protein solution containing immunoglobulins) BIOLOGICAL

* 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

Also known as: alb-prf

albumin-PRF

connective tissue graft BIOLOGICAL

Local anesthesia. Intrasulcular incision around target teeth. Papilla preservation flap. Harvesting CTG from the palate

connective tissue graft

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 20-55 years
• Nordland and Tarnow Class I/II papillary loss
• Good oral hygiene (FMPS \& FMBS \<20%)
• Systemically healthy

You may not qualify if:

• Smoking
• Periodontal pockets \>4 mm in the target site
• History of systemic diseases or medications affecting healing
• Pregnant or lactating women

Sponsors & Collaborators

• shaimaa hamdy: lead

Related Links

• Modified interproximal tunneling technique with customized sub-epithelial connective tissue graft for gingival papilla reconstruction: report of three cases with a cutback incision on the palatal side

MeSH Terms

Interventions

Albumins

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• shaimaa Hamdy, lecturer

  lecturer of periodontology Nahda University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shaimaa Hamdy, lecturer of Periodontology

CONTACT

+201030576405; shimaa.3m.sh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer of oral medicine, oral diagnosis and periodontology

Model Details: Sample Selection: * Inclusion Criteria: * Age 20-55 years * Nordland and Tarnow Class I/II papillary loss * Good oral hygiene (FMPS \& FMBS \<20%) * Systemically healthy * Exclusion Criteria: * Smoking * Periodontal pockets \>4 mm in target site * History of systemic diseases or medications affecting healing * Pregnant or lactating women * 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

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: August 24, 2025
• Study Start: September 1, 2025
• Primary Completion: September 20, 2025
• Study Completion: September 23, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share