Methods for the treatment of peri-implantitis

1. A method for treating a patient suffering from peri-implantitis comprising:

surgically exposing the dental implant in a peri-implant bone loss site in the patient;

debriding and decontaminating the exposed dental implant; and

applying once to the peri-implant bone loss site a dose ranging from 0.1-2 grams of a pharmaceutical composition comprising a biocompatible bone augmentation material coated with a matrix composition,

wherein the matrix composition comprises:

(a) a biocompatible polymer;

(b) a first lipid comprising at least one sterol;

(c) a second lipid comprising at least one phospholipid having fatty acid moieties of at least 14 carbons; and

(d) at least one pharmaceutically active agent,

wherein the at least one pharmaceutically active agent comprises doxycycline or doxycycline hyclate at 0.4-2% (w/w) of the total weight of the pharmaceutical composition, and

wherein said matrix composition provides local sustained release of the pharmaceutically active agent at the pen-implant bone loss site, thereby reducing peri-implantitis defects in the peri-implant bone loss site.

2. The method of claim 1 , wherein the pen-implant disease is further associated with at least one of clinical attachment loss and extensive mucosal recession and/or bleeding on probing.

3. The method of claim 1 , wherein the bone augmentation material is selected from the group consisting of allogeneic, xenogeneic, synthetic bone augmentation materials or any combination thereof.

4. The method of claim 1 , wherein the bone augmentation material comprises beta tri-calcium phosphate (β-TCP) particles.

5. The method of claim 1 , wherein the bone augmentation material comprises particles having an average particle size of up to about 500 μm inclusive.

6. The method of claim 1 , wherein the coated bone augmentation material comprises between about 80-90% (w/w) of bone augmentation material and between about 10-20% (w/w) of the matrix composition.

7. The method of claim 1 , wherein the pharmaceutical composition further comprises non-coated bone augmentation material.

8. The method of claim 7 , wherein the weight ratio between the coated bone augmentation material and the non-coated bone augmentation material is between about 1:3 and about 10:1.

9. The method of claim 1 , wherein the biocompatible polymer is a biodegradable polyester selected from the group consisting of PLA, PGA and PLGA.

10. The method of claim 9 , wherein the biodegradable polyester is present at a weight percentage of up to 2% (w/w) of the total weight of the pharmaceutical composition.

11. The method of claim 1 , wherein the sterol comprises cholesterol.

12. The method of claim 11 , wherein the cholesterol is present at a weight percentage of up to 0.8% (w/w) of the total weight of the pharmaceutical composition.

13. The method of claim 1 , wherein the pharmaceutically active agent further comprises an anti-inflammatory agent.

14. The method of claim 1 , wherein the pharmaceutical composition comprises a plurality of antibiotic agents.

15. The method of claim 1 , wherein the pharmaceutically active agent is present at 0.4-0.8% (w/w) of the total weight of the pharmaceutical composition.

16. The method of claim 1 , wherein the pharmaceutical composition further comprises an additional active agent which induces or stimulates bone growth.

17. The method of claim 1 , wherein the second lipid comprises a phosphatidylcholine selected from the group consisting of DMPC, DPPC, DSPC, DOPC or any combination thereof.

18. The method of claim 17 , wherein the weight of the combination of phosphatidylcholines constitutes at least 2.5% (w/w) of the total weight of the pharmaceutical composition.

19. A method for treating an oral biofilm at a peri-implant site of a patient, the method comprising:

surgically exposing the dental implant at the pen-implant site in the patient;

debriding and decontaminating the exposed dental implant; and

applying once to a pen-implant bone site a dose ranging from 0.1-2 grams of a pharmaceutical composition comprising a biocompatible bone augmentation material coated with a matrix composition,

wherein the matrix composition comprises:

(a) a biocompatible polymer;

(b) a first lipid comprising at least one sterol;

(c) a second lipid comprising at least one phospholipid having fatty acid moieties of at least 14 carbons; and

(d) at least one pharmaceutically active agent,

wherein the at least one pharmaceutically active agent comprises doxycycline or doxycycline hyclate at 0.4-0.8% (w/w) of the total weight of the pharmaceutical composition, and

wherein said matrix composition provides local sustained release of the pharmaceutically active agent at the pen-implant site.

20. A method for treating a patient suffering from peri-implantitis associated with crestal peri-implant bone loss comprising: surgically exposing the dental implant in the peri-implant bone loss site in the patient; debriding and decontaminating the exposed dental implant; and

applying to a pen-implant bone loss site a pharmaceutical composition comprising coated and non-coated bone augmentation material at a ratio of between about 1:3-10:1,

wherein the coated bone augmentation material comprises between about 80-90% (w/w) of bone augmentation material coated with between about 10-20% (w/w) of a matrix composition which comprises:

(a) 15-25% (w/w) poly (lactic-co-glycolic acid) (PLGA);

(b) 5-15% (w/w) of cholesterol;

(c) 50-70% (w/w) of a mixture of 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (DPPC) and 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC),

wherein the ratio of DPPC to DSPC is between 5:1 and 2:1 and (d) 7-12% (w/w) of doxycycline or doxycycline hyclate.